Running stitch suturing device

ABSTRACT

An instrument and method for suturing wound closures is provided having a handle, shaft and suture engagement mechanism. The instrument provides for multiple placements or “bites” of suture in tissues to enable a wide variety of suturing techniques, including the ability to “run” a suture. The instrument further facilitates suture knot tying. The method of this instrument provides for rapid and effective remote suture placement and knot tying.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of commonly-assigned U.S.patent application Ser. No. 10/757,042 filed Jan. 14, 2004, entitledSEW-RIGHT RUNNING STITCH INSTRUMENT by Jude S. Sauer, et al., thedisclosure of which is incorporated herein.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not applicable.

REFERENCE TO A “SEQUENCE LISTING”

Not applicable.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates generally to surgical suturing instruments andmore particularly to a surgical suturing instrument in which a needlecan be selectively engaged with a fitting at the end of the suture forpulling the suture through a tissue section and released from the suturefor permitting subsequent stitches to be made.

2. Description of Related Art

Invasive therapeutic interventions typically provide for the removal ofproblematic tissue structures from the body followed by a need toreconstruct the involved tissues. Many alternatives are available forreconstructive interventions. Bandages can often close external wounds.The use of sutures placed within wound edges to draw tissues together topermit enhanced healing has become commonplace in modern medicine.Metallic or plastic staples and clips also can be used to appose tissuefor healing.

To minimize the invasiveness of therapeutic procedures, efforts tocreate smaller access wounds that minimize iatrogenic tissue disruptionhave lead to better patient outcomes. For example, a minimally invasivesurgical procedure, like laparoscopic partial colonic resection withintestinal reconnection (anastomosis), can facilitate lessperi-operative pain, more rapid return of normal functions, earlierreturn to home and work. The placement of sutures during laparoscopicsurgery can be slow, tedious and often not successful. Existingspecialized instruments for minimally invasive surgery (Sauer) haverecognized limitations. An instrument to enable the rapid, preciseplacement of multiple suture bites with the same suture and thenfacilitate rapid, secure knot creation would be a significant advance.

BRIEF SUMMARY OF THE INVENTION

Briefly stated and in accordance with certain presently preferredembodiments of the invention, a surgical suturing instrument includes anelongated shaft, a tissue engaging gap formed in an end of the shaft, aneedle reciprocally movable across the gap from a proximal end of thegap to a distal end of the gap, the needle having a ferrule engaging tipand a ferrule receiving aperture at a distal end of the gap forselectively holding and releasing a ferrule so that in a first mode theneedle engages the ferrule and draws the suture across the gap and in asecond mode, the ferrule is retained in the aperture and the needleseparates from the ferrule and is retracted across the gap leaving theferrule in the aperture.

In accordance with another aspect of the invention, a surgical suturinginstrument for placing multiple suture loops in tissue comprises onelongated shaft, a reciprocal suture pick up member mounted on theshaft, a suture holder engaged by the reciprocating suture pick upmember for selectively coupling a suture to the pick up member fordrawing the suture through a first tissue section and releasing thesuture from the pick up member for repeated coupling and drawing thesuture through a second tissue section spaced from the first tissuesection.

In accordance with another aspect of the invention, a surgical suturinginstrument includes reciprocating tissue penetrating member, a sutureholder, and apparatus for alternately coupling the reciprocating tissuepenetrating member to the suture holder for drawing a length of suturethrough a tissue section and releasing the reciprocating tissuepenetrating member from the suture holder.

In accordance with another aspect of the invention, a method of closinga wound includes the steps of disposing a suture on one side of a tissuesection proximal to the wound, passing a needle through the section oftissue proximal to the wound, capturing the suture with the needle,drawing the suture through the section of tissue, releasing the suturefrom the needle, and repeating the passing capturing drawing andreleasing steps.

In accordance with another aspect of the invention, a method of securinga suture at a wound site comprises passing an end of the suture throughbolster and securing the suture with a bolster disposed between the endof the suture and the wound.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

The foregoing objects, features and advantages of the invention willbecome more apparent from a reading of the following description inconnection with the accompanying drawings, in which:

FIG. 1 is a perspective view of the tissue suturing instrument inaccordance with the present invention;

FIG. 2 is a partial side view of the tissue suturing instrument of FIG.1 in which the right cover of the housing of the instrument is removed;

FIG. 3 is an exploded perspective view of the tissue suturing instrumentof FIG. 1 in which the right cover of the housing is removed;

FIGS. 4A-4C are perspective views of the thumb slide holder of FIG. 3showing this component from the top left, top right and bottom rightperspectives, respectively;

FIG. 5A is a partially exploded perspective view of the thumb slidemechanism of FIG. 3 highlighting the thumb button and the retaining lockfeatures;

FIG. 5B is a perspective view of an assembled thumb slide mechanism ofFIG. 3 showing the thumb button in its fully out position;

FIG. 6A is a left perspective view of the thumb slide mechanism of FIG.3 with its balled needle fully back and its accompanying lever fullyout;

FIG. 6B is a left perspective view of the thumb slide mechanism of FIG.3 with its balled needle fully forward and its accompanying lever fullyretracted;

FIG. 7A is a right perspective view of the thumb slide mechanism of FIG.3 with its thumb button and ferrule stripper fully back and itsaccompanying lever fully out;

FIG. 7B is a right perspective view of the thumb slide mechanism of FIG.3 with it thumb button and ferrule stripper fully forward and itsaccompanying lever fully retracted;

FIG. 8A is an exploded perspective view of the distal tip of theinstrument of FIG. 1 showing the distal tube, jaw, needle, ferrulestripper and ferrule retainer;

FIG. 8B is a perspective view of the underside of the distal tip of FIG.1 showing the ferrule stripper alignment ramp and the ferrule holdingcompartment;

FIG. 9A is a right perspective view of the drive mechanism of theinstrument of FIG. 3 with the thumb slide holder removed and both thethumb button and the lever are fully out;

FIG. 9B is a right perspective view of the distal tip of the componentsof FIG. 9A showing the ferrule in its compartment;

FIG. 9C is a partial cross-sectional view of the distal tip of thecomponents of FIG. 9A with the ferrule in its compartment and the needleand ferrule stripper fully back;

FIG. 9D is a side view of the proximal components of FIG. 9A showing thelever and thumb button fully out;

FIG. 9E is a right perspective view of the drive mechanism of theinstrument of FIG. 3 with its thumb slide holder removed, the leverpartially retracted and the thumb button fully out;

FIG. 9F is a right perspective view of the distal tip of the componentsof FIG. 9E with the needle partially advanced and the ferrule in itscompartment;

FIG. 9G is the partial cross-sectional view of the distal tip of thecomponents of FIG. 9E showing the ferrule in its compartment, the needlepartially advanced and the ferrule stripper fully back;

FIG. 9H is a side view of the proximal components of FIG. 9E showing thelever partially retracted and the thumb button fully out;

FIG. 9J is a right perspective view of the drive mechanism of theinstrument of FIG. 3 with the thumb slide holder removed, the leverfully retracted and the thumb button fully out;

FIG. 9K is a right perspective view of the distal tip of the componentsof FIG. 9J showing the needle fully advanced and engaging the ferrule inits compartment;

FIG. 9L is a partial cross-sectional view of the distal tip of thecomponents of FIG. 9J with the needle engaging the ferrule in itscompartment and the ferrule stripper fully back;

FIG. 9M is a side view of the proximal components of FIG. 9J showing thelever fully retracted and the thumb button fully out;

FIG. 10A is a right perspective view of the drive mechanism of theinstrument of FIG. 3 with the thumb slide holder removed, with the thumbbutton fully out, the lever partially forward and the needle attached tothe ferrule and suture partially back;

FIG. 10B is a right perspective view of the distal tip of the componentsof FIG. 10A showing the needle attached to the ferrule with suturepartially retracted;

FIG. 10C is a partial cross-sectional view of the distal tip of thecomponents of FIG. 10A showing the needle attached to the ferrule andsuture partially retracted and the ferrule stripper fully back;

FIG. 10D is a side view of the proximal components of FIG. 10A showingthe lever partially back and the thumb button fully out;

FIG. 10E is a right perspective view of the drive mechanism of theinstrument of FIG. 3 with the thumb slide holder removed, the leverfully out and the thumb button fully out;

FIG. 10F is a right perspective view of the distal tip of the componentsof FIG. 10E showing the needle attached to the ferrule and suture fullyretracted and the ferrule stripper fully back;

FIG. 10G is a perspective side view of the distal tip of the componentsof FIG. 10E showing the needle attached to the ferrule and suture fullyretracted and the ferrule stripper fully back;

FIG. 10H is a side view of the proximal components of FIG. 10E showingthe lever fully out and the thumb button fully out;

FIG. 11A is a right perspective view of the drive mechanism of theinstrument of FIG. 3 with the thumb slide holder removed, the leverpartially retracted, the needle with its ferrule and suture partiallyadvanced and the thumb button fully out;

FIG. 11B is a right perspective view of the distal tip of the componentsof FIG. 11A showing the needle attached to the ferrule and the suturepartially advanced;

FIG. 11C is a partial cross-sectional view of the distal tip of thecomponents of FIG. 11A showing the needle attached to the ferrule andthe suture partially advanced and the ferrule stripper fully back;

FIG. 11D is a side view of the proximal components of FIG. 11A showingthe lever partially retracted and the thumb button fully out;

FIG. 11E is a right perspective view of the drive mechanism of theinstrument of FIG. 3 with the thumb slide holder removed and the leverfully retracted and the thumb button fully out;

FIG. 11F is a right perspective view of the distal tip of the componentsof FIG. 11E with the needle fully advanced along with its attachedferrule and suture;

FIG. 11G is a partial cross-sectional view of the distal tip of thecomponents of FIG. 11E showing the needle along with its attachedferrule and suture fully advanced into the ferrule compartment;

FIG. 11H is a side view of the proximal components of FIG. 11E showingthe lever fully retracted and the thumb button fully out;

FIG. 11J is a close-up side view of the lock features of the componentsof FIG. 11H showing the flat engagement surface of the actuating memberraising the proximal spring lock to disengage it from the timing tube;

FIG. 12A is a right partial view of the drive mechanism of theinstrument of FIG. 3 with the thumb slide holder removed, the leverfully retracted, the needle with its attached ferrule and suture fullyadvanced and the thumb button partially advanced;

FIG. 12B is a right perspective view of the distal tip of the componentsof FIG. 12A showing the needle with its ferrule and suture fullyadvanced into the ferrule compartment and the ferrule stripper partiallyadvanced;

FIG. 12C is a partial cross-sectional view of the distal tip of thecomponents of FIG. 12A showing the needle attached to the ferrule andsuture fully advanced and the ferrule stripper partially advanced;

FIG. 12D is a side view of the proximal components of FIG. 12A showingthe lever fully retracted and the thumb button partially forward;

FIG. 12E is a close-up side view of the lock features of the componentsof FIG. 12D showing the flat engagement surface of the actuating memberraising the proximal spring lock and the timing tube partially forward;

FIG. 12F is a right perspective view of the drive mechanism of theinstrument of FIG. 3 with the thumb slide holder removed, the leverfully retracted, the needle with its attached ferrule and suture fullyadvanced, and the thumb button and ferrule stripper fully forward;

FIG. 12G is a right perspective view of the distal end of the componentsof FIG. 12F showing the needle with its ferrule and suture fullyadvanced and the ferrule stripper fully advanced and engaging theferrule;

FIG. 12H is a partial cross-sectional view of the distal tip of thecomponents of FIG. 12F showing the needle attached to the ferrule andthe suture and the ferrule stripper fully advanced engaging the ferrule;

FIG. 12J is the side view of the proximal components of FIG. 12F showingboth the lever and the thumb button fully forward;

FIG. 12K is a close-up side view of the lock features of FIG. 12Jshowing the flat engagement surface of the actuating member raising theproximal spring lock, the timing tube fully forward and engaging thereleased distal spring lock;

FIG. 13A is a right perspective view of the drive mechanism of theinstrument of FIG. 3 with the thumb slide holder removed, the leverpartially released, the needle partially retracted, the ferrule stripperengaging the ferrule in its ferrule compartment and the thumb buttonfully forward;

FIG. 13B is a right perspective view of the distal tip of the componentsof FIG. 13A showing the needle partially retracted and the ferrulestripper fully forward;

FIG. 13C is a partial cross-sectional view of the distal tip of thecomponents of FIG. 13A showing the needle partially retracted and theferrule stripper fully forward engaging the ferrule in its compartment;

FIG. 13D is a side view of the proximal components of FIG. 13A showingthe lever partially out and the thumb button fully forward;

FIG. 13E is a close-up side view of the lock features of FIG. 13Dshowing the convex engagement surface of the actuating member raisingthe distal spring lock and the thumb button released but still fullyforward;

FIG. 13F is a right perspective view of the drive mechanism of theinstrument of FIG. 3 with the thumb slide holder removed, the lever,needle, thumb button and ferrule stripper partially back;

FIG. 13G is a right perspective view of the distal tip of the componentsof FIG. 13F with the needle and ferrule stripper partially retracted andthe ferrule back into its compartment;

FIG. 13H is a partial cross-sectional view of the distal tip of thecomponents of FIG. 13F showing the needle and the ferrule stripperpartially back and the ferrule and suture in the ferrule compartment;

FIG. 13J is a side view of the proximal components of FIG. 13F showingthe lever and the thumb button partially back;

FIG. 13K is a close-up side view of the lock features of FIG. 13Fshowing the engagement surfaces of the actuating member not raisingeither of the spring locks;

FIG. 13L is a right perspective view of the drive mechanism of theinstrument of FIG. 3 with the thumb slide holder removed, the lever,needle, thumb button and ferrule stripper fully back and the ferrule andsuture reloaded into the ferrule compartment;

FIG. 13M is a perspective view of the distal tip of the components ofFIG. 13L showing the needle and ferrule stripper fully retracted and theferrule and suture in the ferrule compartment;

FIG. 13N is a partial cross-sectional view of the distal tip of thecomponents of FIG. 13L showing the needle and ferrule stripper fullyback and the ferrule and suture in the ferrule compartment;

FIG. 13P is a side view of the proximal components of FIG. 13L showingthe lever and the thumb button fully back;

FIG. 13R is a close-up side view of the lock features of FIG. 13Lshowing the proximal spring clip engaging the timing tube;

FIGS. 14A-14E show an example of the suturing procedure using the tissuesuturing instrument of FIG. 1 for placement of suture at the first siteof the wound closure;

FIGS. 15A-15E show an example of the suturing procedure using the tissuesuturing instrument of FIG. 1 for placement of suture at the second siteof the wound closure;

FIGS. 16A-16D show an example of the suturing procedure using the tissuesuturing instrument of FIG. 1 for placement of suture at the third siteof the wound closure;

FIGS. 17A-17D show an example of the suturing procedure using the tissuesuturing instrument of FIG. 1 for placement of suture at the fourth siteof the wound closure;

FIGS. 18A-8E show an example of the use of the instrument of FIG. 1 toenable suture loop construction to initiate the tying of a suture knot;

FIGS. 19A-19F show an example of the instrument of FIG. 1 to constructfurther suture loops used to secure a suture knot;

FIG. 20 shows the suturing instrument of FIG. 1 used with a surgicalgrasper, which pulls on the free end of the suture to deliver the sutureknot to the wound closure site;

FIG. 21 shows both the suturing instrument of FIG. 1 and a surgicalgrasper pulling on either ends of the suture to lock the knot in placeto secure the wound closure;

FIGS. 22A-22C show an alternate method of securing the ends of thesuture used in the suturing procedure illustrated in FIGS. 14A-17D bycrimping a sleeve member over the ends of the suture;

FIGS. 23A-23D illustrate a running suturing procedure created using thetissue suturing instrument of FIG. 1 being secured by bolsters and acrimped sleeve member;

FIG. 24A is a perspective view of the distal tip of the second preferredembodiment of the tissue suturing instrument of FIG. 1 in which astripper wedge causes a flexible member to grasp the ferrule;

FIG. 24B is a partial cross-sectional view of the distal tip of thesecond preferred embodiment of the tissue suturing instrument of FIG. 1showing the needle engaging the ferrule and partial deployment of thestripper wedge;

FIG. 24C is a partial cross-sectional view of the distal tip of thesecond preferred embodiment of the tissue suturing instrument of FIG. 1showing the stripper wedge engaging the flexing member which grasps theferrule and allows the needle to retract leaving the ferrule in itsferrule compartment;

FIG. 25A is a perspective view of the distal tip of the third preferredembodiment of the tissue suturing instrument of FIG. 1 in which astripper rod passes through the distal tip and engages the proximal faceof the ferrule to enable stripping;

FIG. 25B is a broken-out section of the distal tip of the thirdpreferred embodiment of the tissue suturing instrument of FIG. 1 inwhich a stripper rod rests in its internal chamber as the needle engagesthe ferrule in its ferrule pocket;

FIG. 25C is a broken-out section of the distal tip of the thirdpreferred embodiment of the tissue suturing instrument of FIG. 1 inwhich the stripper rod protrudes from its internal chamber to engage theproximal face of the ferrule as the needle disengages the ferrule andretracts;

FIG. 26 is a partially exploded isometric view of the fourth preferredembodiment of the tissue suturing instrument of FIG. 1 in which a camand follower mechanism and faceted needle are utilized to allow forautomatic ferrule pick-up and release;

FIG. 27A is a close-up isometric view of the cam and follower mechanismof the fourth preferred embodiment of the tissue suturing instrument ofFIG. 1 illustrating the needle fully retracted;

FIG. 27B is a close-up perspective view of the tip of faceted needle ofthe fourth preferred embodiment of the tissue suturing instrument ofFIG. 1 shown in its ferrule engaging configuration;

FIG. 27C is a close-up isometric view of the cam and follower mechanismof the fourth preferred embodiment of the tissue suturing instrument ofFIG. 1 illustrating the needle partially advanced and the followermechanism actuating the cam and rotating the needle;

FIG. 27D is a close-up perspective view of the tip of faceted needleshown partially rotated as it is advancing;

FIG. 27E is a close-up isometric view of the cam and follower mechanismof the fourth preferred embodiment of the tissue suturing instrument ofFIG. 1 illustrating the needle fully advanced;

FIG. 27F is a close-up perspective view of the tip of faceted needle ofthe fourth preferred embodiment of the tissue suturing instrument ofFIG. 1 shown fully advanced and rotated to its ferrule strippingconfiguration;

FIG. 28 is a close-up perspective view of the distal tip of the fourthpreferred embodiment of the tissue suturing instrument of FIG. 1 showinga partially advanced faceted needle, the ferrule in its ferrulecompartment and a ferrule latch adjacent to the ferrule pocket;

FIG. 29A is a close-up perspective view of the stripping mechanism ofthe fourth preferred embodiment of the tissue suturing instrument ofFIG. 1 showing the ferrule latch disengaged and allowing the facetedneedle to retrieve the ferrule;

FIG. 29B is a close-up perspective view of the stripping mechanism ofthe fourth preferred embodiment of the tissue suturing instrument ofFIG. 1 showing the ferrule latch engaged and enabling the stripping ofthe faceted needle from the ferrule;

FIG. 30A is a partial cross-sectional view of the distal tip of thefourth preferred embodiment of the tissue suturing instrument of FIG. 1showing the faceted needle fully retracted and the ferrule in itsferrule compartment;

FIG. 30B is a partial cross-sectional view of the distal tip of thefourth preferred embodiment of the tissue suturing instrument of FIG. 1showing the faceted needle fully extended, disengaging the ferrulelatch, and connecting with the ferrule in its ferrule compartment;

FIG. 30C is a partial cross-sectional view of the distal tip of thefourth preferred embodiment of the tissue suturing instrument of FIG. 1showing the faceted needle beginning to retract with its attachedferrule and suture;

FIG. 30D is a partial cross-sectional view of the distal tip of thefourth preferred embodiment of the tissue suturing instrument of FIG. 1showing the faceted needle retracting with its attached ferrule andsuture and the ferrule latch returning to its normal state;

FIG. 30E is a partial cross-sectional view of the distal tip of thefourth preferred embodiment of the tissue suturing instrument of FIG. 1showing the faceted needle fully retracted with its attached ferrule andsuture;

FIG. 30F is a partial cross-sectional view of the distal tip of thefourth preferred embodiment of the tissue suturing instrument of FIG. 1showing the faceted needle extending and returning the ferrule and itssuture to the ferrule compartment;

FIG. 30G is a partial cross-sectional view of the distal tip of thefourth preferred embodiment of the tissue suturing instrument of FIG. 1showing the faceted needle fully extended, the ferrule and its suturereturned to the ferrule compartment and the ferrule latch engaged withthe proximal face of the ferrule;

FIG. 30H is a partial cross-sectional view of the distal tip of thefourth preferred embodiment of the tissue suturing instrument of FIG. 1showing the faceted needle retracting and the ferrule latch retainingthe ferrule in its ferrule compartment;

FIG. 30J is a partial cross-sectional view of the distal tip of thefourth preferred embodiment of the tissue suturing instrument of FIG. 1showing the faceted needle fully retracted and awaiting the next cycleof firing of the instrument;

FIG. 31 is a perspective view of the tissue suturing instrument inaccordance with another embodiment of the present invention;

FIG. 32 is a partial side view of the tissue suturing instrument of FIG.31 in which the right cover of the housing has been removed;

FIG. 32A is an enlarged partial side view of the distal tip of thetissue suturing instrument of FIG. 31.

FIG. 33 is an exploded perspective view of the tissue suturinginstrument of FIG. 31 in which the right cover of the housing has beenremoved.

FIG. 34A and 34B are perspective views of the lever of FIG. 33 showingthis component from the distal top and proximal top perspectives,respectively;

FIG. 35 is a perspective view of the selector mechanism of FIG. 33highlighting the balled needle selection and balled needle liberationfeatures;

FIG. 36 is perspective view of the selector shuttle of FIG. 33highlighting the balled needle retention features;

FIG. 37A is a right perspective view of the lever and balled needleselector mechanism of FIG. 33 with the lever fully advanced and itsaccompanying balled needles fully back and the selector mechanismpositioned over the left balled needle;

FIG. 37B is a right perspective view of the lever and balled needleselector mechanism of FIG. 33 with the lever fully retracted forcing theleft balled needle to advance while allowing the right balled needle toremain retracted;

FIG. 38A is a right perspective view of the lever and balled needleselector mechanism of FIG. 33 with the lever fully advanced and itsaccompanying balled needles fully back and the selector mechanismpositioned over the right balled needle;

FIG. 38B is a right perspective view of the lever and balled needleselector mechanism of FIG. 33 with the lever fully retracted forcing theright balled needle to advance while allowing the left balled needle toremain retracted;

FIG. 39A is a right perspective view of the lever and selector mechanismof FIG. 33 with the lever fully advanced and its accompanying balledneedles fully back and the selector mechanism positioned over the leftballed needle with its follower in the left advancing track of thelever;

FIG. 39B is a right perspective view of the lever and selector mechanismof FIG. 33 with the lever fully retracted forcing the left balled needleto advance while allowing the right balled needle to remain retractedwith the follower of the selector mechanism in the left advancing trackof the lever;

FIG. 39C is a right perspective view of the lever and selector mechanismof FIG. 33 with the lever returned to its fully advanced position andits accompanying balled needles fully back and the selector mechanismpositioned over the left balled needle with its follower in the leftadvancing track of the lever;

FIG. 39D is a right perspective view of the lever and selector mechanismof FIG. 33 with the lever fully advanced and its accompanying balledneedles fully back and the selector mechanism now positioned over theright balled needle with its follower traversing the selection track ofthe lever;

FIG. 39E is a right perspective view of the lever and selector mechanismof FIG. 33 with the lever fully retracted forcing the right balledneedle to advance while allowing the left balled needle to remainretracted with the follower of the selector mechanism in the rightadvancing track of the lever;

FIG. 39F is a right perspective view of the lever and selector mechanismof FIG. 33 with the lever returned to its fully advanced position andits accompanying balled needles fully back and the selector mechanismpositioned over the right balled needle with its follower in the rightadvancing track of the lever;

FIG. 40A is an exploded perspective view of the adapter and spring armsof FIG. 33 as they are used in the actuation of the rotation cam;

FIG. 40B is a left perspective view of the adapter and spring arms ofFIG. 33 showing the suture routing tube slot and cam bores;

FIG. 41A is a side view of the rotation cam of FIG. 33 showing theadvance/retract tracks, the rotation tracks, and the motion preventionlock-outs;

FIG. 41B is a cross-sectional view of FIG. 41A showing the needle bore,and the ramped track surfaces;

FIG. 41C is a flat-pattern view of the cam profile of FIG. 41A showingthe advance/retract tracks, the rotation tracks, and the motionprevention lock-outs;

FIG. 41D is a perspective view of the rotation cam of FIG. 33 showingthe needle bore, advancing and rotation tracks, advancing and rotationstops, and advancing and rotation ramps;

FIG. 41E is a cross-sectional view of FIG. 41D showing the needle boreas it passes centrally through the rotation cam and the profile of theadvancing track with its ramp and stop;

FIG. 42 is a right perspective view of the balled needle of FIG. 33showing the ferrule latch engaging and disengaging surfaces;

FIG. 42A is a partial side view of FIG. 42 illustrating the ferrulelatch disengaging surfaces without facets;

FIG. 42B is a partial side view of FIG. 42 illustrating the facetedferrule latch engaging surface;

FIG. 43 is a right perspective view of the fully advanced lever and apartial cross-section of the adapter of FIG. 33 as they interface withthe fully retracted balled needle and its accompanying rotation cam;

FIG. 43A is a right perspective view of a partial cross-section of theadapter of FIG. 43 showing the spring arm as it engages in a fullyretracted rotation cam;

FIG. 43B is a partial right perspective view of the tip of the balledneedle of FIG. 43 showing the orientation of the ferrule latch engagingand disengaging faces;

FIG. 44 is a right perspective view of the partially retracted lever anda partial cross-section of the adapter of FIG. 33 as they interface withthe partially advanced balled needle and its accompanying rotation cam;

FIG. 44A is a right perspective view of a partial cross-section of theadapter of FIG. 44 showing the spring arm as it engages in a partiallyadvanced rotation cam;

FIG. 45 is a right perspective view of the fully retracted lever and apartial cross-section of the adapter of FIG. 33 as they interface withthe fully advanced balled needle and its accompanying rotation cam;

FIG. 45A is a right perspective view of a partial cross-section of theadapter of FIG. 45 showing the spring arm as it engages in a fullyadvanced rotation cam;

FIG. 45B is a partial right perspective view of the tip of the balledneedle of FIG. 45 showing the orientation of the ferrule latch engagingand disengaging faces;

FIG. 46 is a right perspective view of the lever partially returned toits fully advanced state and a partial cross-section of the adapter ofFIG. 33 as they interface with the balled needle and its accompanyingrotation cam as they are partially returned to their fully retractedstate;

FIG. 46A is a right perspective view of a partial cross-section of theadapter of FIG. 46 showing the spring arm as it engages in the rotationcam as it rotates during its partial return to its fully retractedposition;

FIG. 46B is a partial right perspective view of the tip of the balledneedle of FIG. 46 showing the orientation of the ferrule latch engagingand disengaging faces as the cam begins to rotate as it is beingretracted;

FIG. 47 is a right perspective view of the now fully advanced lever anda partial cross-section of the adapter of FIG. 33 as they interface withthe balled needle and its accompanying rotation cam as they are fullyretracted;

FIG. 47A is a right perspective view of a partial cross-section of theadapter of FIG. 47 showing the spring arm as it engages in the rotationcam as it completes its rotation upon returning to its fully retractedposition;

FIG. 47B is a partial right perspective view of the tip of the balledneedle of FIG. 47 showing the orientation of the ferrule latch engagingand disengaging faces as the cam completes its rotation and is fullyretracted;

FIG. 48 is an exploded perspective view of the underside of the distaltip of the instrument of FIG. 31 showing the sew tip and the ferrulelatch;

FIG. 49A is a perspective view of the ferrule latch of FIG. 48 depictinghow the ferrule latch flexes in relation to the pocketed ferrules whenencountered by the ferrule latch engaging face of left balled needle;

FIG. 49B is a perspective view of the ferrule latch of FIG. 48 depictinghow the ferrule latch flexes in relation to the pocketed ferrules whenencountered by the ferrule latch engaging face of right balled needle;

FIG. 50A is a perspective view of the underside of the distal tipassembly of the instrument of FIG. 31 illustrating both balled needlesfully retracted and the ferrule latch retaining both sutures andattached ferrules best depicting the lever and cam operations shown inFIGS. 43 and 43A, respectively;

FIG. 50B is a perspective view of the underside of the distal tipassembly of the instrument of FIG. 31 illustrating the right balledneedle fully retracted, the left balled needle partially advanced, andthe ferrule latch retaining both sutures and attached ferrules bestdepicting the lever and cam operations shown in FIGS. 44 and 44A,respectively;

FIG. 50C is a perspective view of the underside of the distal tipassembly of the instrument of FIG. 31 illustrating the right balledneedle fully retracted, the left balled needle fully advanced andengaging the ferrule latch to release only the left suture and attachedferrule best depicting the lever and cam operations shown in FIGS. 45and 45A, respectively;

FIG. 50D is a perspective view of the underside of the distal tipassembly of the instrument of FIG. 31 illustrating the right balledneedle fully retracted, the left balled needle beginning its retractionand rotation while retaining the left suture and attached ferrule anddisengaging the ferrule latch allowing it to return to its normal statebest depicting the lever and cam operations shown in FIGS. 46 and 46B,respectively;

FIG. 50E is a perspective view of the underside of the distal tipassembly of the instrument of FIG. 31 illustrating the right and leftballed needles fully retracted and pulling the left suture and attachedferrule across the jaw best depicting the lever and cam operations shownin FIGS. 47 and 47A, respectively;

FIG. 50F is a perspective view of the underside of the distal tipassembly of the instrument of FIG. 31 illustrating the right balledneedle fully retracted, the left balled needle partially advanced andbeginning to return the left suture and attached ferrule to its pocketbest depicting the lever and cam operations shown in FIGS. 44 and 44A,respectively;

FIG. 50G is a perspective view of the underside of the distal tipassembly of the instrument of FIG. 31 illustrating the right balledneedle fully retracted, the left balled needle fully advanced andreturning the left suture and attached ferrule to its pocket while notengaging the ferrule latch best depicting the lever and cam operationsshown in FIGS. 45 and 45A, respectively;

FIG. 50H is a perspective view of the underside of the distal tipassembly of the instrument of FIG. 31 illustrating the right balledneedle fully retracted, the left balled needle beginning its retractionand rotation while both sutures and attached ferrules are retained bythe ferrule latch allowing it to return to its normal state bestdepicting the lever and cam operations shown in FIGS. 46 and 46A,respectively;

FIG. 50J is a perspective view of the underside of the distal tipassembly of the instrument of FIG. 31 illustrating both balled needlesfully retracted and the ferrule latch retaining both sutures andattached ferrules best depicting the lever and cam operations shown inFIGS. 47 and 47A, respectively;

FIGS. 51A-51H illustrate a method of tying a unique knot with theinstrument 16 of FIG. 31.

DETAILED DESCRIPTION OF THE INVENTION

The first preferred embodiment of this invention, suturing instrument16, is represented in FIGS. 1-13R. Referring to FIGS. 1-3, show thesuturing instrument 16, which represents the SEW-RIGHT SR·5 manufacturedby LSI SOLUTIONS, Inc. (formerly LaserSurge, Inc.) of Victor, N.Y., thathas been modified to provide a means for selectably stripping itsferrule 103 from the needle 34 at its tissue engaging end 16 a. Thetissue engaging end 16 a and needle 34 thereto may be similar to thatshown in U.S. Pat. Nos. 5,431,666, 5,766,183, European Patent No. EP0669101, filed Feb. 23, 1995 and granted Oct. 14, 1998, or U.S. PatentApplication Publication No. US 2002/0107530 A1, filed Feb. 2, 2001,which are herein incorporated by reference.

The housing 30 has a body shaped like a pistol having a handle portion30 a, and may be made of a two-piece construction of molded plastic. Aneedle 34 extends from housing 30 through the shaft 16 b into the tissueengaging end 16 a. Needle 34 has a non-tissue engaging end 34 b in thehousing 30 having a spherical member 34 a, such as a ball or bearing,respectively, attached thereto. The needle 34 and spherical member 34 amay be made of metal, such as surgical stainless steel. The sphericalmember 34 a may have a bore into which the non-tissue engaging end 34 bof the needle 34 extends and joins thereto, such as by welding orbrazing.

The suturing instrument 16 includes an actuating member 36 representinga lever 36 a having two pins 36 b extending into holes 30 b in the sidesof housing 30 upon which the actuating member 36 is pivotally mounted inthe housing 30. Actuating member 36 has a portion which extends througha lever opening 30 c (FIG. 2) in housing 30 to enable pivotal movementabout pins 36 b. An extension spring 38 is provided which hooks at oneend in a notch 36 c of actuating member 36 and is wound at the other endaround a pin 40 located in holes 30 f in the sides of housing 30, suchthat the actuating member 36 is spring biased to retain actuating member36 normally in a forward position, fully out, as shown for example inFIG. 2. The body of housing 30 has a front pivot stop 30 e (FIG. 3)providing a stop that limits the pivotal movement of the actuatingmember 36. A notch 36 c is provided in the actuating member 36 which isshaped to receive the non-engaging end of needle 34, i.e., sphericalmember 34 a, to be driven forward by an operator pulling actuatingmember 36 to pivot actuating member 36 towards handle portion 30 a. Thegroove 36 d (FIG. 3) is provided by two fingers 36 e into which theneedle 34 near the spherical member 34 a may lie.

As shown in FIGS. 4B and 4C, a thumb slide holder 42 is fixed in housing30 by two flanges 42 a above actuating member 36. As best shown in FIG.4A, the thumb slide holder 42 has a chamber 42 b with a groove 42 dformed by fingers 42 e which allow the needle 34 to be received inchamber 42 b to restrict movement of the needle 34 when held therein.The lower surface 42 f of thumb slide holder 42 is curved and facescorrespondingly curved upper surface 36 f of actuating member 36, suchthat the actuating member 36 is slidable along lower surface 42 fresponsive to the operator pulling the actuating member 36.

The adapter 48 has a bore extending there through in which a needlespreader 50 is located. Needle spreader 50 has two channels 50 b and 50c into which needle 34 and ferrule stripper 35 are respectively locatedto increase the distance between the needle 34 and the ferrule stripper35 as they extend toward thumb slide holder 42, such that the needle 34and ferrule stripper 35 are properly aligned.

A suture routing tube 47 is provided for suture thread in housing 30.Suture routing tube 47 has one end received in a valve assembly 19, atthe bottom of handle portion 30 a of housing 30 and then extends throughthe suture routing tube notch 30 d (FIG. 3) along the interior of theleft side of housing 30, and a groove 50 a along needle spreader 50(FIG. 3). The other end of the suture routing tube 47 is then mounted insuture routing tube hole 51 a through gasket 51. Gasket member 51further has two holes 51 b and 51 c through which needle 34 and ferrulestripper 35, respectively extend. The gasket 51 may be made of medicalgrade rubber, such as Santoprene.

A longitudinal guide member 53 is provided multiple tracks along itslength, including two tracks 53 a and 53 b for needle 34 and ferrulestripper 35, respectively, and a suture track 53 c for suture 105extending from opening 51 a of gasket 51. The guide member 53 may bemade of extruded flexible material, such as Tecoflex®. A D-tube 52 isprovided which is D-shaped at one end 52 a is registered into acorresponding shaped opening in adapter 48, and a threaded nut 54 havingan opening which extends over D-tube 52, screws onto the end of theadapter 48 to secure D-tube 52 to housing 30. With the gasket 51 loadedfirst into D-tube 52, guide member 53 extends from the gasket 51 throughthe D-tube 52. In this manner, tracks 53 a, 53 b, and 53 c each form achannel with the interior surface of D-tube 52. D-tube 52 may be made ofstainless steel, or other rigid material, and has for example, D-tube 52has an outside diameter of 0.203 inches. (Note for other applications,such as flexible endoscopy, this tube could be flexible.) Inside D-tube52, gasket 51 has a ring 51 d, which frictionally engages the interiorsurface of D-tube 52. Hole 51 a of the gasket 51 is of a diameter suchthat the suture tube 47 tightly fits therein and provides a seal aroundsuture tube 47. The suture tube 47 may be held in place in hole 51 a byfriction, but adhesive may also be used. Holes 51 b and 51 c are of alarger diameter than the needle 34, except for a small section of holes51 b and 51 c where the diameter reduces to form flaps of gasketmaterial which seal around needle 34 and ferrule stripper 35,respectively. This enables movement of the needle 34 and ferrulestripper 35 tube back and forth while maintaining a seal about theneedle 34 and ferrule stripper 35. One feature of the gasket 51 is thatit enables sealing the shaft 16 b as well.

The guide member 53 is received into the D-tube 52, such that guidemember 53 abuts gasket 51 and engages distal tip 98. Distal tip 98 isattached to the D-tube 52 by mechanical fastening by forming small dents52 c in the metal of the D-tube 52 with a press into recessed fourpockets 98 b (FIG. 3), i.e., two on each side of the distal tip 98.

An optional valve assembly 19 can be provided at the bottom of handleportion 30 a, as shown in FIG. 3, having a valve seat 19 a and a valvecontroller 19 b. Valve seat 19 a is composed of medical grade rubber,such as Santoprene®, and has a through hole extending into an interiorchamber. A valve controller 19 b composed of molded plastic, or otherrigid material, has a circular section through an opening and a surfaceforming a cam that can be turned to select a valve fully open tointermediate partially open to a fully closed position. The suturerouting tube 47 is received in hole 76 of valve seat 19 a, as shown inFIG. 3, such that suture 105 material from the tube can pass throughopenings of the valve seat 19 a and then through the valve controller 19b.

Referring to FIGS. 2 and 3, the tissue engaging end 16 a of the suturinginstrument 16 is shown having the distal tip 98 which is mounted in aD-tube 52, such that the front section 98 a of the distal tip 98 extendsfrom D-tube 52.

Referring to FIGS. 4A-4C, the thumb slide holder 42 is shown. The thumbslide holder 42 may be made of a one-piece construction of moldedplastic. The thumb slide holder 42 is fixed in the housing 30 above theactuating member 36 by two opposing flanges 42 a, as best shown in FIG.4B.

As best represented in FIG. 4A, the thumb slide holder 42 has a chamber42 b through which the positive stop 41 b of the timing tube 41 c islocated. One groove 42 d formed by two fingers 42 e allows the needle 34(FIG. 3) to pass through the thumb slide holder 42 through the groove 36d formed by the two fingers 36 e of the actuating member 36 and enablesthe spherical member 34 a to rest in the notch 36 c of the actuatingmember 36. The lower curved surface 42 f extends over the curved uppersurface 36 f of the actuating member 36 to further retain the needle 34and spherical member 34 a in the notch 36 c throughout the entire rangeof motion of the actuating member 36.

The housing 42 g of the thumb slide holder 42 is fashioned toaccommodate and guide the thumb button 41 e (FIG. 3). The thumb buttonstop 42 k serves as a motion-limiting surface to prevent the thumbbutton 41 e from traveling farther than intended. The thumb slide holder42 has a bore 42 c for the timing tube 41 c (FIG. 3) is located.Contained within the housing 42 g is a raised region 42 h to enablealignment of the return spring 46 (FIG. 3) and resting surface 42 jwhich seats and retains the return spring 46.

FIG. 4C shows a perspective view of the thumb slide holder 42 and timingtube stop 42 l which provides a positive engagement surface for thepositive stop 41 b to limit the advance of the timing tube 41 c. Thethumb slide holder 42 may further have a channel 42 p forward of thegroove 42 d to provide clearance for suture routing tube 47 (FIG. 3).The body of the thumb slide holder 42 has lock spring bores 42 n andspring lock channels 42 m to provide for the assembly, alignment, andretaining of the lock springs 45 and distal spring lock 43 and proximalspring lock 44, respectively and best represented in FIGS. 5A and 5B.

FIG. 5A shows the push button assembly 41 interfacing with othercomponents. The timing tube 41 c is shown with the thumb button 41 eattached thereto. Housed inside the thumb button 41 e is the returnspring 46 which serves as a return mechanism for the assembly. Theferrule stripper 35 is received into the distal opening 41 d and coupledto the timing tube 41 c via an insert molding or adhesive process. Thelock springs 45 are inserted into the thumb slide holder 42 and followedwith the proximal spring lock 44 and the distal spring lock 43. With theproximal spring lock 44 and the distal spring lock 43 inserted in thethumb slide holder 42 and compressed, the push button assembly 41 withattached ferrule stripper 35 is inserted into the thumb slide holder 42such that the positive stop 41 b passes into the chamber 42 b and theproximal spring lock engages in the spring lock engagement slot 41 a.The ferrule stripper 35 continues through the adapter 48.

FIG. 5B shows a perspective view of the underside of assembled pushbutton assembly 41, thumb slide holder 42, adapter 48, nut 54, andD-tube 52 and highlights the relative location of the proximal springlock 44 and distal spring lock 43.

Referring to FIGS. 6A and 6B, the operation of the actuating member 36and the needle 34 is described. As the actuating member 36 is engaged,rotating about the pins 36 b, the needle 34 and the attached sphericalmember 34 a are advanced as the spherical member 34 a is in contact withthe notch 36 c of the actuating member 36.

FIGS. 7A and 7B illustrate the operation of the push button assembly 41and the ferrule stripper 35. The actuating member 36 is engaged,rotating about the pins 36 b until the flat engagement surface 36 gcomes into contact with and forces the proximal spring lock 44 out ofthe spring lock engagement slot 41 a (FIG. 5A) allowing the forwardmotion of the push button assembly 41 and the coupled ferrule stripper35. This forward motion is limited primarily by the engagement of distalspring lock 43 with spring lock engagement slot 41 a (FIG. 5A).Advancement of timing tube 41 c is also limited by engaging the adapter48.

FIG. 8A shows the assembly of the distal tip 98 and the ferrule retainer99 with the D-tube 52, the needle 34, and the ferrule stripper 35. Thedistal tip 98 has a gap 104 in a c-shaped jaw 104 having two openings 98c at one side of the gap through which each needle 34 and ferrulestripper 35 may extend The needle 34 and the ferrule stripper 35 arereceived into the needle/stripper openings of the distal tip 98 and thedistal tip 98 is then coupled to the D-tube 52 which may be achieved bymechanical fastening forming small dents in the metal of the D-tube 52with a press into four recessed pockets 98 b, i.e., two on each side ofthe distal tip 98. The ferrule retainer 99 is inserted into the ferruleretainer hole 98 e until the ring 99 a seats into the opening createdwhere the ferrule retainer hole 98 e intersects the ferrule pocket 107as best shown in FIG. 8B. The suture 105 attached to the ferrule 103enters the ferrule compartment 107 through the open slot located on theside of the ferrule chamber opposite from the ferrule retainer 99.

FIGS. 9A-13R represent highlights of twelve sequential steps overviewingthe loading, reloading and locking operations through one complete cycleof use of instrument 16. For example, the first three steps presented inFIGS. 9A-9M, illustrate the needle 34 first advancing into the ferrule103.

FIGS. 9A-9D show the instrument loaded and ready for use, the firststep. FIG. 9A shows a right perspective view of the drive mechanism ofthe instrument of FIG. 3 with the thumb slide holder 42 removed and boththe thumb button 41 e and the lever 36 a are fully out; the proximalspring lock 44 engages the timing tube 41 c. FIG. 9B is a rightperspective view of the distal tip 98 of the components of FIG. 9Ashowing the ferrule 103 in its ferrule compartment 107 and the jaw 104.FIG. 9C is a partial cross-sectional view of the distal tip 98 of thecomponents of FIG. 9A with the ferrule 103 in its ferrule compartment107, and the needle 34 and ferrule stripper 35 fully back. FIG. 9D is aside view of the proximal components of FIG. 9A showing the lever 36 aand thumb button 41 fully out. Proximal spring lock 44 is shown engagingspring lock engagement slot 41 a of timing tube 41 c.

FIGS. 9E-9H show partial advancement of the needle 34 as part of thesecond step. FIG. 9E is a right perspective view of the drive mechanismof the instrument of FIG. 3 with its thumb slide holder 42 removed, thelever 36 a partially retracted and the thumb button 41 e fully out. FIG.9F is a right perspective view of the distal tip 98 of the components ofFIG. 9E with the needle 34 partially advanced and the ferrule 103 in itsferrule compartment 107. FIG. 9G is the partial cross-sectional view ofthe distal tip 98 of the components of FIG. 9E showing the ferrule 103in its ferrule compartment 107, the needle 34 partially advanced and thestripper 35 fully back. FIG. 9H is a side view of the proximalcomponents of FIG. 9E showing the lever 36 a partially retracted and thethumb button 41 e fully out.

FIGS. 9J-9M show the needle 34 fully advanced and engaged inside of theferrule 103 as part of the third step. FIG. 9J is a right perspectiveview of the drive mechanism of the instrument of FIG. 3 with the thumbslide holder 42 removed, the lever 36 a fully retracted and the thumbbutton 41 e fully out. FIG. 9K is a right perspective view of the distaltip 98 of the components of FIG. 9J showing the needle 34 fully advancedto engage the ferrule 103 in its ferrule compartment 107; best shown inFIG. 9L. FIG. 9L is a partial cross-sectional view of the distal tip 98of the components of FIG. 9J with the needle 34 engaging the ferrule 103in its ferrule compartment 107 and the ferrule stripper 35 fully back.FIG. 9M is a side view of the proximal components of FIG. 9J showing thelever 36 a fully retracted and the thumb button 41 e fully out. Notethat the flat engagement surface 36 g is shown raising the proximalspring lock 44 out of the spring lock engagement slot 41 a.

The next two steps presented in FIGS. 1A-10H, illustrate the needle 34,now attached to the ferrule 103 and its suture 105, being retractedfully back. FIGS. 1A-10D show the needle 34 pulling its ferrule 103 backthrough jaw 104. FIG. 10A is a right perspective view of the drivemechanism of the instrument of FIG. 3 with the thumb slide holder 42removed, with the thumb button 41 e fully out, the lever 36 a partiallyforward and the needle 34 attached to the ferrule 103 and suture 105partially back. FIG. 10B is a right perspective view of the distal tip98 of the components of FIG. 10A showing the needle 34 attached to theferrule 103 with suture 105 partially retracted. FIG. 10C is a partialcross-sectional view of the distal tip 98 of the components of FIG. 10Ashowing the needle 34 attached to the ferrule 103 and suture 105partially retracted and the ferrule stripper 35 fully back. FIG. 10D isa side view of the proximal components of FIG. 10A showing the lever 36a partially back and the thumb button 41 e fully out;

FIGS. 10E-10H show this instrument 16 with the ferrule 103 and itssuture 105 attached to the fully retracted needle 34. FIG. 10E is aright perspective view of the drive mechanism of the instrument of FIG.3 with the thumb slide holder 42 removed, the lever 36 a fully out andthe thumb button 41 e fully out. FIG. 10F is a right perspective view ofthe distal tip 98 of the components of FIG. 10E showing the suture 105fully retracted and the ferrule stripper 35 fully back. FIG. 10G is aperspective side view of the distal tip 98 of the components of FIG. 10Eshowing the needle 34 attached to the ferrule 103 and suture 105 fullyretracted and the ferrule stripper 35 fully back. FIG. 10H is a sideview of the proximal components of FIG. 10E showing the lever 36 a fullyout and the thumb button 41 e fully out.

FIGS. 11A-11J show the next two steps representing reinsertion of theferrule 103 into it ferrule compartment 107. FIGS. 11A-11E show thepartial advancement of the needle 34 with its attached ferrule 103 andsuture 105. FIG. 11A is a right perspective view of the drive mechanismof the instrument of FIG. 3 with the thumb slide holder 42 removed, thelever 36 a partially retracted, the needle 34 with its ferrule 103 andsuture 105 partially advanced and the thumb button 41 e fully out. FIG.11B is a right perspective view of the distal tip 98 of the componentsof FIG. 11A showing the needle 34 attached to the ferrule 103 and thesuture 105 partially advanced. FIG. 11C is a partial cross-sectionalview of the distal tip 98 of the components of FIG. 11A showing theneedle 34 attached to the ferrule 103 and the suture 105 partiallyadvanced and the ferrule stripper 35 fully back. FIG. 11D is a side viewof the proximal components of FIG. 11A showing the lever 36 a partiallyretracted and the thumb button 41 e fully out.

FIGS. 11E-11J show the needle 34 fully advanced attached to the ferrule103 and its suture 105. Note that at this step of the operation, FIG.11J is provided to show an enlarged view of the distal spring lock 43and proximal spring lock 44. FIG. 11E is a right perspective view of thedrive mechanism of the instrument of FIG. 3 with the thumb slide holder42 removed and the lever 36 a fully retracted and the thumb button 41 efully out. FIG. 11F is a right perspective view of the distal tip 98 ofthe components of FIG. 11E with the needle 34 fully advanced into theferrule 103. FIG. 11G is a partial cross-sectional view of the distaltip 98 of the components of FIG. 11E showing the needle 34 along withits attached ferrule 103 and suture 105 fully advanced into its ferrulecompartment 107. FIG. 11H is a side view of the proximal components ofFIG. 11E showing the lever 36 a fully retracted and the thumb button 41e fully out. FIG. 11J is a close-up side view of the lock features ofthe components of FIG. 11H showing the flat engagement surface 36 g ofthe actuating member 36 raising the proximal spring lock 44 to disengageit from the spring lock engagement slot 41 a of the timing tube 41 c.

FIGS. 12A-12K illustrate the next two steps to complete advancement ofthe ferrule stripper 35. FIGS. 12A-12E show the advancing of the pushbutton assembly 41 to partially advance towards stripping the ferrule103 from the fully advanced needle 34. FIG. 12A is a right partial viewof the drive mechanism of the instrument of FIG. 3 with the thumb slideholder 42 removed, the lever 36 a fully retracted, the needle 34 withits attached ferrule 103 and suture fully advanced and the thumb button41 e partially advancing the ferrule stripper 35. FIG. 12B is a rightperspective view of the distal tip 98 of the components of FIG. 12Ashowing the needle 34 with its ferrule 103 and suture 105 fully advancedinto its ferrule compartment 107 and the ferrule stripper 35 partiallyadvanced. FIG. 12C is a partial cross-sectional view of the distal tip98 of the components of FIG. 12A showing the needle 34 attached to theferrule 103 and suture 105 fully advanced and the ferrule stripper 35partially advanced.

FIG. 12D is a side view of the proximal components of FIG. 12A showingthe lever 36 a fully retracted and the thumb button 41 e and itsattached timing tube 41 c partially forward. FIG. 12E is a close-up sideview of the lock features of the components of FIG. 12D showing the flatengagement surface 36 g raising the proximal spring lock 44 out of thespring lock engagement slot 41 a and the timing tube 41 c partiallyforward.

FIGS. 12F-12K show the full advancement of both the needle 34 andferrule stripper 35. FIG. 12F is a right perspective view of the drivemechanism of the instrument of FIG. 3 with the thumb slide holder 42removed, the lever 36 a fully retracted, the needle 34 with its attachedferrule 103 and suture 105 fully advanced, and the thumb button 41 eadvancing its ferrule stripper 35 fully forward. FIG. 12G is a rightperspective view of the distal end of the components of FIG. 12F showingthe needle 34 with its ferrule 103 and suture 105 fully advanced and theferrule stripper 35 fully advanced and engaging the proximal edge of theferrule 103, as best shown in FIG. 12H. FIG. 12H is a partialcross-sectional view of the distal tip 98 of the components of FIG. 12Fshowing the needle 34 attached to the ferrule 103 and the suture 105 andthe ferrule stripper 35 fully advanced and flexed onto the needle 34 toengage the proximal edge of the ferrule 103. FIG. 12J is the side viewof the proximal components of FIG. 12F showing both the lever 36 a andthe thumb button 41 e fully forward. FIG. 12K is a close-up side view ofthe lock features of FIG. 12J showing the actuating member 36 raisingthe proximal spring lock 44, allowing the distal spring lock 43 toengage the spring lock engagement slot 41 a in the timing tube 41 c.Note a relief 36 j in the top of the actuating member 36 allows thedistal spring lock 43 to travel downward and engage the spring lockengagement slot 41 a.

The last three steps, FIGS. 13A-13R, illustrate the complete retractionof both the needle 34 and ferrule stripper 35. FIGS. 13A-13E show thelever 36 a partially forward to retract the needle 34 to strip theferrule 103 by engaging ferrule 103 with the fully advanced ferrulestripper 35. FIG. 13A is a right perspective view of the drive mechanismof the instrument of FIG. 3 with the thumb slide holder 42 removed, thelever 36 a partially released, the needle 34 partially retracted, theferrule stripper 35 engaging the ferrule 103 in its ferrule compartment107 and the thumb button 41 e fully forward.

FIG. 13B is a right perspective view of the distal tip 98 of thecomponents of FIG. 13A showing the needle 34 partially retracted fromits ferrule 103 (not visible in this view) and the ferrule stripper 35fully forward. FIG. 13C is a partial cross-sectional view of the distaltip 98 of the components of FIG. 13A showing the needle 34 partiallyretracted and the ferrule stripper 35 fully forward engaging the ferrule103 in its ferrule compartment 107. FIG. 13D is a side view of theproximal components of FIG. 13A showing the lever 36 a partially out andthe thumb button 41 e fully forward. FIG. 13E is a close-up side view ofthe lock features of FIG. 13D showing the convex engagement surface 36 hof the actuating member 36 (FIG. 13D) raising the distal spring lock 43to disengage the spring lock engagement slot 41 a of the timing tube 41c.

FIGS. 13F-13K show both the needle 34 and ferrule stripper 35 partiallyreturning with the ferrule 103 replaced back into its ferrulecompartment 107. FIG. 13F is a right perspective view of the drivemechanism of the instrument of FIG. 3 with the thumb slide holder 42removed, the lever 36 a, needle 34, thumb button 41 e and ferrulestripper 35 partially back. FIG. 13G is a right perspective view of thedistal tip 98 of the components of FIG. 13F with the needle 34 andferrule stripper 35 partially retracted and the ferrule 103 back intoits ferrule compartment 107. FIG. 13H is a partial cross-sectional viewof the distal tip 98 of the components of FIG. 13F showing the needle 34and the ferrule stripper 35 partially back and the ferrule 103 andsuture 105 in the ferrule compartment 107. FIG. 13J is a side view ofthe proximal components of FIG. 13F showing the lever 36 a and the thumbbutton 41 e partially back. FIG. 13K is a close-up side view of the lockfeatures of FIG. 13F showing the engaging surfaces 36 f-36 h of theactuating member 36 not raising the proximal spring lock 44 or thedistal spring lock 43 with the spring lock engagement slot 41 areleased.

FIGS. 13L-13R show the instrument reloaded, ready for use and areidentical to FIGS. 9A-9D, respectively, while FIG. 13R highlightsre-engagement of the proximal spring lock 44 with the spring lockengagement slot 41 a. FIG. 13L is a right perspective view of the drivemechanism of the instrument of FIG. 3 with the thumb slide holder 42removed, the lever 36 a, needle 34, thumb button 41 e and ferrulestripper 35 fully back and the ferrule 103 and suture 107 reloaded intothe ferrule compartment 107. FIG. 13M is a perspective view of thedistal tip 98 of the components of FIG. 13L showing the needle 34 andferrule stripper 35 fully retracted and the ferrule 103 and suture 107in the ferrule compartment 107. FIG. 13N is a partial cross-sectionalview of the distal tip 98 of the components of FIG. 13L showing theneedle 34 and ferrule stripper 35 fully back and the ferrule 103 andsuture 107 in the ferrule compartment. FIG. 13P is a side view of theproximal components of FIG. 13L showing the lever 36 a and the thumbbutton 41 e fully back. FIG. 13R is a close-up side view of the lockfeatures of FIG. 13L showing the proximal spring lock 44 engaging thespring lock engagement slot 41 a of the timing tube 41 c.

Now referencing FIGS. 14A-17D, showing the multiple placement of suturesto form a wound closure. FIGS. 14A-14E illustrate the use of thisinstrument for the placement of the first suture of a wound closure andthe readiment of the instrument for subsequent bites. FIG. 14A shows thedistal tip 98 of the instrument 16 above a wound closure 110. Note thedistal side of the wound closure 110 has crosshatching for purposes ofthis illustration. FIG. 14B shows the device 16 with the needle 34passing through the first bite 124 of the distal side of the wound 110.FIG. 14C shows the needle 34 retracted back with its ferrule 103 andsuture 105 pulled through the wound 110. FIG. 14D shows the needle 34now advanced through to place the ferrule 103 back into its ferrulecompartment 107. FIG. 14E shows the needle 34 back after having itsferrule 103 stripped. The instrument is now ready for another bite.

Now referencing FIGS. 15A-15E, the device 16 is again placed into thewound 110 this time with the proximal side of the wound 110 in theinstrument's jaw 104. The needle 34 will enter the tissue 120 as shownin FIG. 15A, traverse the tissue 120 and enter the ferrule compartment107 as shown in FIG. 15B. FIG. 15C illustrates the needle 34, ferrule103 and suture 107 pulled back leaving suture 105 through the first bite126 on the proximal side of the wound closure 110. FIG. 15D shows theneedle 34 advanced yet again. FIG. 15E shows the ferrule 103 back in itsferrule compartment 107.

FIG. 16A-16D shows the second suture placement on the distal side of thewound 110. FIG. 16A shows the needle 34 traversing the second site 127on the distal wound 110 aspect. FIG. 16B shows the suture 105 throughthe second bite 127 on the distal side of the wound 110. FIG. 16C showsthe needle 34, ferrule 103 and suture 105 advanced to the ferrulepocket. FIG. 16D shows the instrument again ready for the bite.

FIG. 17A-17D show the second bite 128 on the proximal side of the woundclosure 110. FIG. 17A shows the needle 34 going through the second site128 of the proximal side of the wound closure 110. FIG. 17B shows theneedle 34, ferrule 103 and suture 105 advanced back into its ferrulecompartment 107. FIG. 17C shows the instrument with the ferrule 103reloaded and the needle 34 and ferrule stripper 35 retracted back. FIG.17D illustrates the appearance of the wound closure 110. If the sutures105 were to be tied at this time, this type of closure is commonlycalled a figure of eight suture closure. If the process were to continuewith further placements of suture 105 running along the distal andproximal aspects of the wound closure, this type of closure is typicallybe called a running suture wound closure.

Now referencing FIGS. 18A-21, FIG. 18A shows the instrument 16 of thisinvention with the distal tail of the suture 105 exposed and the distaltip 98 of the instrument 16 ready for knot tying. FIGS. 18A-19B show thefirst throw of the knot tying process. FIGS. 19C-19F show the secondthrow of the knot tying process. FIGS. 21 and 22 show the cinching downof the knot. In FIG. 18B, a surgical grasper 129, is used to grab thefree end of the suture 105 and to wrap the suture 105 around the jaw 104of the instrument 16. Note that to construct the unique knot of thisinvention, which we have named the “Super Surgeon's knot,” the firstwrapping of suture 105 around the jaw 104 consists of two complete loopswrapped around the jaw 104. FIG. 18C shows the advancement of the needle34, ferrule 103 and suture 105 back into its ferrule compartment 107,best shown in FIG. 18A, after the double wrap has been placed around thejaw 104 of the instrument 16. FIG. 18D shows the now stripped ferrule103 in its ferrule compartment 107. FIG. 18E shows the knot formingdouble loops being slid down towards the wound closure site 110. FIG.19A shows the grasper 129 further cinching the knot down to the woundclosure site 110. FIG. 19B shows the suture 105 now fully retracted backon its needle 34 to further expose the jaw 104 of the knot tyinginstrument 16. FIG. 19C shows a second wrapping of a single loop placedaround the distal tip 98 of the instrument 16 to secure the knot. FIG.19D shows the needle 34 again advanced to replace the ferrule 103 in itsferrule compartment 107 along with the suture 105. FIG. 19E shows theferrule 103 in its ferrule compartment 107 with the needle 34 andferrule stripper 35 now back. FIG. 19F shows the second throw, a singleloop throw, of the Super Surgeon's knot being slid over the ferrule 103and suture 105 down towards the wound closure 110. FIG. 20D illustratesthat by pulling on the surgical grasper 129 on the free end of thesuture 105, the suture loops are further slid towards and down onto thewound closure 110 to begin to pull (also called approximate or appose)the edges of the wound 110 together, but not fully locking the knot inplace. FIG. 21 shows by pulling on the surgical grasper 129 holding thefree end of the suture 105, and now by simultaneously pulling oninstrument 16 holding the ferrule 103 end of the suture 105, both endsof the suture 105 are drawn tight, thereby locking the Super Surgeon'sknot in place. The distinct advantage of the Super Surgeon's knot isthat it permits the user to place the knot above the wound closure andappropriately appose the wound edge by pulling only on the free end ofthe suture, and then, once the correct tissue apposition is achieved,the user can pull on the ferrule end of the suture to lock the knotdown. Locking down the Super Surgeon's knot alone provides adequateholding force, at least temporarily, to hold together many types ofwound closures. For example, a Super Surgeon's knot made with 2-0STRONGSORB® suture by LSI SOLUTIONS, Inc., achieves an average tissueholding strengths of approximately 0.5 kg knot holding force totemporarily secure and tissue edges together. Subsequent throws on topof the Super Surgeon's knot will add additional knot holding force up tothe native strength of the suture (e.g., with 2-0 STRONGSORB®, up to 5to 6 kg tensile pull). No other knot is known (to the inventors) thatcan be constructed under such surgically relevant conditions andprovides excellent tissue holding force immediately when the firstthrows are drawn together by pulling on both ends of the suture.

FIGS. 22A-22C illustrate an alternate method of securing the free endsof the suture 105 left by the instrument 16, used to close the wound 110in the tissue 120. FIG. 22A represents an instrument 130, which crimps asleeve member 121 to secure suture 105 together and is commerciallyavailable as a Ti-KNOT® TK·5. Device manufactured by LSI SOLUTIONS,Inc., under at least the following patents U.S. Pat. Nos.: 5,520,702;5,643,289 and 5,669,917. The free ends of the suture 105 are passedthrough the instrument 130 and the instrument 130 is passed closer tothe wound closure 110. FIG. 22B illustrates the instrument 130 beingapplied directly to the wound closure 110 and both free ends of thesuture 105 drawn tight, removing any slack and drawing the opposingsides of the wound closure 110 closer together. FIG. 22C shows thesleeve member 121 crimped around the suture 105 at the wound closure110. Note that the suture 105 has been trimmed.

After using instrument 16 to place suture 105 for running a woundclosure 110, one or both ends of the suture 105 may remain unsecured.These free ends of the suture 105 can be attached to pledgets orbolsters 122 a and 122 b to prevent their ability to be pulled into oraway from the wound site 110. A pledget is typically a pliable,non-reactive piece of material, such as polyester mesh, Gortex®, or thelike, that is often used in conjunction with sutures or staples toaugment wound closures. In this invention, a bolster 122 a is attached(e.g., by tying or sewing) to one end of an additional segment of suture123 a. By placing the free end of this bolstered suture 123 a, alongwith one free end of the suture 105, the bolster 122 a and its attachedsuture 123 a can be passed down using suture 105 as a guide. Bolster 122a, suture 123 a and one end of suture 105 can be secured at one end ofthe wound site 110 with a sleeve member 121. The bolster 122 a can holdthis end of the running suture 105 from being pulled into the wound 110.By repeating a similar bolstered suture 123 b placement at the oppositeend of the wound 110, the second bolster 122 b and its suture 123 b canhold the second suture 105 end from being pulled into the wound 110.Bolsters 122 a and 122 b secured at each end of the wound 110, preventthe suture 105 from being pulled out of the wound 110 from eitherdirection.

FIGS. 24A-24C illustrate a second preferred embodiment of thisinvention. The main difference between this embodiment and the firstpreferred embodiment, is that instead of stripping the ferrule 103 withthe ferrule stripper 35 traversing the gap and engaging the ferrule 103,the member that directly contacts the ferrule 103 for ferrule strippingis incorporated in the distal tip 98. The thumb button 41 e drivemechanism for this embodiment can be the same as in the first preferredembodiment. FIG. 24A shows a perspective of the distal jaw, which lookssimilar to the first embodiment, except instead of a slope to direct thestripper wedge 131 towards the ferrule, the stripper wedge 131 enters achamber 141 and subsequently wedges member 133 against ferrule 103 topermit removal of the needle 34. FIG. 24B shows needle 34 engagingferrule 103 in ferrule compartment 107 with the stripper wedge 131traveling toward chamber 141. FIG. 24C shows the ferrule 103 held in itsferrule compartment 107 by stripper wedge 131 forcing over member 133.Needle 34 can now be extracted from ferrule 103. Stripper wedge 131 canbe subsequently withdrawn leaving the ferrule 103 in it reloadedposition.

FIGS. 25A-25C illustrate a third preferred embodiment of this invention.In this embodiment, unlike the prior two, the ferrule stripping elementdoes not traverse the gap in the distal tip 98. Rather, in thisembodiment, the stripper wedge 131, which can be a semi-flexiblematerial, such as memory metal, Nitinol, or the like, passes through achannel in the bridge that traverses behind the gap in the jaw. Thisferrule stripping embodiment can also be advanced towards the ferruleusing a mechanism similar to the already described thumb slide mechanism41 (FIG. 3). FIG. 25A shows needle 34 after being retracted back andstripped off ferrule 103 held in its ferrule compartment 107 by theflexible integrated stripper 135. FIG. 25B is a partial sectional viewof needle 34 engaging ferrule 103 in its ferrule compartment 107. Theflexible integrated stripper 135 is shown retracted into the bridgechannel 134 to permit the needle 34 to pull the ferrule 103 out of itsferrule compartment 107. FIG. 25C illustrates a partially retractedneedle after its ferrule 103 is stripped by the flexible integratedstripper 135.

FIGS. 26-30J describe a fourth preferred embodiment of this invention.Unlike the previous three embodiments, this fourth version does notrequire an additional manual mechanism, like the thumb slide mechanism,to enable ferrule stripping. Instead of pushing a button to activate astripper, this instrument is more automated to enable stripping theferrule 103 imply squeezing the lever 36 a a second time.

FIG. 26 shows this instrument in a perspective view illustrating window136 in the right handle half; a comparable window (not shown) is locatedin the opposite location on the left handle half. These windows permitan instrument user to view from either handle an asymmetric rotatingdisc 138 a that indicates whether the cam needle 139 is in the stripperor non-stripper orientation. Also, note rod 137 mounts into the righthandle half to engage the slots in the rotating cam 138. When lever 36 arotates back, cam 138 drives forward, lifts towards the mid stroke, thenlowers and rotates about rod 137, as seen in FIGS. 27A-27C.

FIG. 27A shows the rod 137 engaging the distal slot in cam 138. Therotating indicator disc 138 a is vertically oriented indicating anon-faceted edge of the cam needle 139 faces the ferrule latch 140 (FIG.27A; also see FIGS. 28-31J). Release of the lever 36 a permits the camneedle 139 and its rotational cam 138 to travel back and elevatesslightly at mid stroke, where rod 137 enters an obliquely oriented slot,to begin rotating the rotational cam 138 and its attached cam needle 139(FIG. 27E). By completion of the lever 36 a, the full rotation of therotational cam 138 (FIG. 27A), the needle facet 139 b (FIG. 27F) is noworiented towards the ferrule latch 140, which permits ferrule stripping.

FIG. 28 shows the partially retracted cam needle 139 having its ferrule103 held by ferrule latch 140. Note this illustration shows a pocket 142recessed in the distal tip 98 for holding the ferrule latch 140.

FIG. 29A shows cam needle 139 oriented with a non-faceted shoulder 139 cengaging and lifting the ferrule engaging surface 140 g of the ferrulelatch 140. The ferrule 103 is not held by the ferrule latch 140, becausethe ferrule 103 latch 140 is compressed by the non-faceted shoulder 139c pushing against timing surface 140 b. The ferrule 103 is able to bepulled from its ferrule compartment 107 by cam needle 139. FIG. 29Bshows the distal end of the fourth preferred embodiment with cam needle139 retracting back through the gap and the ferrule latch 140 engaginginto the proximal edge of ferrule 103. FIG. 29B highlights cam needle139 oriented to have a facet 139 b towards the ferrule latch 140, to notengage timing surface 140 b so that the ferrule engagement surface 140 gcontacts the proximal edge of ferrule 103. Surfaces 140 f and 140 eprovide contacts to help maintain latch placement in its pocket 142.

FIGS. 30A-30J show one complete cycle of the cam needle 139 traversingthe jaw 104, picking up a ferrule 103, the ferrule 103 being returned toits ferrule compartment 107 and the ferrule 103 being stripped by theferrule latch 140. This cycle reloads the ferrule 103 for another stitchplacement. FIG. 30 shows the retracted cam needle 139 oriented with anon-faceted shoulder 139 c facing the ferrule latch 140, which securesthe ferrule 103 with its suture 105 in its ferrule compartment 107 inthe distal tip 98. FIG. 30B shows cam needle 139 fully advanced intoferrule 103, with its non-faceted shoulder 139 c compressing ferrulelatch 140. FIG. 30C shows cam needle 139 pulling ferrule 107 and suture105 back beyond the compressed ferrule latch 140. At approximately themidpoint of the cam needle 139 retraction, cam needle 139 begins itsrotation with ferrule 103 and suture 105 rotating with cam needle 139.FIG. 30E shows cam needle 139 along with its ferrule 103 and suture 105fully retracted back with its 900 rotation completed. FIG. 30F shows camneedle 139, ferrule 103 and suture 105 advancing back into ferrulecompartment 107. A faceted shoulder 139 a of cam needle 139 now facesthe ferrule latch 140. FIG. 30G shows the cam needle 139, ferrule 103and suture 105 fully placed back into its ferrule compartment 107. Thefaceted shoulder 139 a of cam needle 139 does not cause ferrule latch140 to compress up or deflect away from the proximal edge of ferrule103. FIG. 30H shows the retraction of ferrule 103 stopped by ferrulelatch 140, stripping ferrule 103 from its partially retracted cam needle139. FIG. 30J shows the cam needle 139 now fully retracted back androtated back 180° so that the opposite side of the non-faceted shoulder139 c is oriented towards the ferrule latch. The ferrule 103 is reloadedback into its ferrule compartment 107 and cam needle 139 is ready toadvance through more tissue 120, picking up ferrule 103 and pulling italong with its suture 105 back through another bite of tissue 120.

An additional embodiment of the invention, suturing instrument 16, isrepresented in FIGS. 31-50J. Referring to FIGS. 31-33, show the suturinginstrument 16, which represents the SEW-RIGHT® SR·5® manufactured by LSISOLUTIONS, Inc. (formerly LaserSurge, Inc.) of Victor, N.Y., that hasbeen modified to provide a means for both selecting a left needle 144 orright needle 145 via a selector mechanism 146 and selectably stripping aferrule 103 from the left needle 144 or right needle 145 at its tissueengaging end 16 a.

A shaft 147 offers a suture loading window 147 a through which a suture105 loaded at the tissue engaging end 16 a may be passed into a suturechannel 150 a of a guide member 150 and subsequently through theinstrument 16 and out of a valve controller 19 b.

The housing 143 has a body shaped like a pistol having a handle portion143 a, and may be made of a two-piece construction of molded plastic. Aleft needle 144 and right needle 145 extend from housing 143 through theshaft opening 143 c into the shaft 147 and proceeds into the tissueengaging end 16 a. Left needle 144 and right needle 145 have anon-tissue engaging end 144 a and 145 a, respectively, in the housing143 having a spherical member 148, such as a ball or bearing, attachedthereto. The left needle 144, right needle 145, and spherical member 148may be made of metal, such as surgical stainless steel. The sphericalmember 148 may have a bore into which the non-tissue engaging end 144 aor 145 a of the left needle 144 or right needle 145, respectively,extends and joins thereto, such as by welding or brazing.

The suturing instrument 16 includes an actuating member 149 representinga lever 149 a having two pins 149 b extending into holes 143 b in thesides of housing 143 upon which the actuating member 149 is pivotallymounted. The lever 149 a of actuating member 149 extends through a leveropening 143 d (FIG. 32) in housing 143 to enable pivotal movement aboutpins 149 b. An extension spring 38 is provided which hooks at one end ina notch 149 c of actuating member 149 and is wound at the other endaround a pin 40 located in holes 143 d in the sides of housing 143, suchthat the actuating member 149 is spring biased to retain actuatingmember 149 normally in a forward position, fully advanced, as shown forexample in FIG. 32. The body of housing 143 has a front pivot stop 143 e(FIG. 32 and 33) providing a stop that limits the pivotal movement ofthe actuating member 149. Grooves 149 d are provided in the actuatingmember 149 which are shaped to retain the non-tissue engaging ends 144 aand 145 a of the left needle 144 and right needle 145, respectivelyaccompanied by a channel 149 e shaped to accept a shuttle 151 thatshaped to accommodate the spherical member 148 to be driven forward byan operator pulling the actuating member 149 to pivot actuating member149 towards handle portion 143 a.

An adapter 154 is fixedly attached to the inside of the housing 143 bymeans of opposing flanges 154 d. Through the adapter 154, the remainderof the components of the instrument 16 are assembled. The selectormechanism 146 is stationed on the post 154 through the post hole 146 c(FIG. 35).

A suture routing tube 47 is provided for the unobstructed passage ofsuture 105 in housing 143. Suture routing tube 47 has one end receivedin valve assembly 19 at the bottom of handle portion 143 a of housing143 and extends through the suture routing tube notch 143 h (FIG. 33)along the interior of the left side of the housing 143, through arouting tube passageway 154 e along the left side of the adapter 154(FIG. 40B). The other end of the suture routing tube 47 is then mountedin a suture routing tube hole 51 a in gasket member 51. Gasket member 51further has two needle holes 51 b and 51 c through which right needle145 and left needle 144 respectively extend. The gasket 51 may be madeof medical grade rubber, such as Santoprene®.

A longitudinal guide member 150 provides multiple tracks along itslength, including a suture channel 150 a for unhindered passage ofsuture 105 extending from opening 51 a of gasket 51, a left needlechannel 150 b to aid in guidance of the left needle 144 as it extendstowards the distal tip 16 a of instrument 16, and a right needle track150 c to aid in the guidance of the right needle 145 as it extendstowards the distal tip 16 a of instrument 16. The guide member 150 maybe made of an extruded flexible material such as Tecoflex®. A shaft 147is provided in which a D-shaped end 147 b is registered into acorresponding shaped opening in adapter 154, and a threaded nut 54having an opening which extends over shaft 147, screws onto the end ofthe adapter 154 to secure the shaft 147 to the adapter 154. With thegasket member 51 loaded first into the shaft 147, guide member 150inserted into the shaft 147 through a distal opening 147 c extends fromthe gasket member 51 through the shaft 147. In this manner, channels 150a, 150 b, and 150 c each form a passage with the interior surface ofshaft 147. The left needle channel 150 b and right needle channel 150 cserve as guides to direct the passage of the left needle 144 and rightneedle 145, respectively, as well to prevent loss of motion that may beencountered if the needles 144 and 145 meet resistance and the build upof stress causes the needles 144 and 145 to undulate. The suture channelprovides a smooth bore through which suture 105 can pass freely on itspath through gasket member 51, suture routing tube 47 and out ofinstrument 16 through the valve controller 19 b. The shaft 147 may bemade of stainless steel, or other rigid material, and has for example anoutside diameter of 0.203 inches. (Note for other applications, such asflexible endoscopy, this tube could be flexible.) Inside shaft 147,gasket member 51 has a ring 51 d, which frictionally engages theinterior surface of shaft 147. Suture routing tube hole 51 a of thegasket member 51 is of a diameter such that the suture routing tube 47fits tightly therein and provides a seal around suture routing tube 47.The suture routing tube 47 may be held in place in the suture routingtube hole 51 a by friction alone, but an adhesive may also be used. Leftneedle hole 51 c and right needle hole 51 b are of a larger diameterthan the left and right needles 144 and 145, respectively, except for asmall section of holes 51 c and 51 b where the diameter reduces to formflaps of gasket material which seal around the left and right needles144 and 145, respectively. This enables movement of the left and rightneedle 144 and 145, respectively back and forth while maintaining a sealabout the left needle 144 and right needle 145. One feature of thegasket member 51 is that it enables sealing of the shaft 147 as well.

The guide member 150 is received into the shaft 147 such that the guidemember 150 abuts the gasket member 51 and engages a distal tip 152. Thedistal tip 152 is fixedly attached into the distal opening 147 c of theshaft 147 by a mechanical means such a metal deformation in which smalldents 147 d are formed and the metal displaced in the shaft 147 isforced into the four recessed pockets 152 b (FIG. 33), i.e., two on eachside of the distal tip 152.An optional valve assembly 19 can be providedat the bottom of the handle portion 143 a of housing 143, as shown inFIG. 33, having a valve seat 19 a and a valve controller 19 b. Valveseat 19 a is composed of a medical grade rubber, such as Santoprene®,and has a through hole 76 extending into an interior chamber. A valvecontroller 19 b composed of molded plastic, or other rigid material, hasa circular section through an opening and a surface forming a cam thatcan be turned to select a valve fully open to intermediate partiallyopen to a fully closed position. The suture routing tube 47 is receivedin hole 76 of valve seat 19 a, as shown in FIG. 33, such that suture 105material can pass through openings of the valve seat 19 a and thenthrough the valve controller 19 b.

Referring to FIGS. 32 and 33, the tissue engaging end 16 a of thesuturing instrument 16 is shown having the distal tip 152 which ismounted in a shaft 147, such that the front section 152 a of the distaltip 152 extends from the shaft 147. Where FIG. 32A is an enlargedpartial side view of the distal tip 152 showing the front section 152 a,the jaw opening 152 f, and the ferrule latch pocket 152 g, all of thedistal tip 152, along with a ferrule latch 153 showing the tissueengaging end 16 a of instrument 16 as it is fixed to the shaft 147.

As shown in FIGS. 34A and 34B, an actuating member 149 is pivotallymounted in holes 143 b of housing 143 via two pins 149 b. The actuatingmember can be constructed of a molded plastic. A pair of grooves 149 daccepts and contain the non-tissue engaging ends 144 a and 145 a of theleft needle 144 and right needle 145, respectively, guiding thespherical members 148 into the channel 149 e which accommodates ashuttle 151. By maneuvering the shuttle 151 across the channel 149 e,either the left needle 144 or right needle 145 can be selected toadvance. For instance, if the shuttle 151 is positioned to the left sideof the actuating member 149, the left needle 144 will advance upon theretracting action of the actuating member 149. The right needle 145 willremain stationary throughout the pivotal range of the actuating member149 due to the clearance profile 149 f. This embodiment includes amechanism to prevent selection of the left needle 144 or right needle145 during a sequence of operation that could damage the instrument. Itis preferred to select the left needle 144 or right needle 145 onlybefore actuating the lever 149 a. The actuating member 149 has a leftadvancing track 149 g, a right advancing track 149 h, and a selectiontrack 149 j located along the surface of the clearance profile 149 f.While a follower pin 146 c of a selector mechanism 146 (FIG. 35) engagesin the left advancing track 149 g of the actuating member 149, theselector mechanism 146 cannot be manipulated until the actuating member149 is returned to its full advanced state. At this point, and only thispoint, the follower pin 146 c of the selector mechanism 146 can traversethe selection track 149 j so that a shuttle 151 can be manipulated tocapture a spherical member 148 of the left needle 144 or right needle145 to allow advancement.

FIG. 35 represents a selector mechanism 146 of FIG. 33. The arm 146 a isattached through a post hole 146 c to the post 154 c of the adapter 154(FIG. 33) such that the selector mechanism 146 can only be manipulatedin a back and forth motion. The arm 146 a extends out of the selectorslot 143 g in the housing 143 to allow an operator to manipulate theselector mechanism 146 to select the left needle 144 or the right needle145. The selection of the left or right needle 144 or 145, respectively,is accomplished by a shuttle actuator 146 b incorporated into the arm146 a of the selector mechanism 146. A shuttle groove 146 e envelopes atongue 151 a protruding from a shuttle 151. The movement of the selectormechanism 146 thus causes the shuttle 151 to the change position andshroud a spherical member 148 of either the left needle 144 or the rightneedle 145 to allow for either the left needle 144 or the right needle145 to advance. A spherical member channel 146 g of selector mechanism146 provides clearance for the spherical members 148 so that the shuttle151 can travel freely across the channel 149 e of the actuating member149 (FIG. 33). A needle clearance 146 f is provided to allow the leftneedle 144 or right needle 145 (whichever is not being advanced) toremain free of contact with moving components and subsequently remainstationary. A follower pin 146 d of selector mechanism 146 is providedto engage in the left advancing track 149 g, right advancing track 149h, and the selector track 149 j to prevent selection operations atinappropriate stages of the instrument 16 cycle of operation. Theselector mechanism 146 can be made of molded plastic or other rigidmaterial

FIG. 36 illustrates a shuttle 151 that, through a ball pocket 151 b,encompasses a spherical member 148 to allow for either left needle 144or right needle 145 advancement. The shuttle 151, and its rail 151 c,sits in a channel 149 e of the actuating member 149 such that it allowsfree lateral movement while preventing component disassembly similar toa ball-and-socket joint.

FIGS. 37A-38B depict the instrument 16 in a partial right perspectiveview with the housing 143 removed. The illustrations clarify thedeployment of the selector mechanism 146, the actuation of the actuatingmember 149, and the subsequent retraction of the left needle 144 and theright needle 145.

FIG. 37A is a partial right perspective view of the instrument 16 withthe housing 143 removed. The arm 146 a of selector mechanism 146 ispositioned over the left needle 144 thus locating the shuttle actuator146 b and shuttle 151 onto the left needle 144. The actuating member 149is fully advanced and both the left needle 144 and the right needle 145are fully retracted.

FIG. 37B is a partial right perspective view of the instrument 16 withhousing 143 removed. The arm 146 a of selector mechanism 146 ispositioned over the left needle 144. The actuating member 149 is fullyretracted as evidenced by the rearward motion of the lever 149 arotating about pins 149 b. The shuttle 151 in channel 149 e exits theshuttle actuator 146 b and fully advances the left needle 144 while thenon-tissue engaging end 145 a of the right needle 145 is unobstructed bythe needle clearance 146 f of the shuttle actuator 146 b of the selectormechanism 146 allowing the right needle 145 to remain fully retracted.

FIG. 38A is a partial right perspective view of the instrument 16 withthe housing 143 removed and the actuating member 149 in its fullyadvanced position. The arm 146 a of selector mechanism 146 is positionedover the right needle 145 thus locating the shuttle actuator 146 b andshuttle 151 onto the right needle 145. With the actuating member 149fully advanced, both the left needle 144 and the right needle 145 arefully retracted.

FIG. 38B is a partial right perspective view of the instrument 16 withhousing 143 removed. The arm 146 a of selector mechanism 146 ispositioned over the right needle 145. The actuating member 149 is fullyretracted as evidenced by the rearward motion of the lever 149 arotating about pins 149 b. The shuttle 151 in channel 149 e exits theshuttle actuator 146 b and fully advances the right needle 145 while thenon-tissue engaging end 144 a of the left needle 144 is unobstructed bythe needle clearance 146 f of the shuttle actuator 146 b of the selectormechanism 146 allowing the left needle 144 to remain fully retracted.

FIGS. 39A-39F detail one complete cycle of an actuation sequence ofinstrument 16. The views depict the instrument 16 in a proximal partialright perspective view with the housing 143 removed. The views highlightthe function of the selector mechanism 146 and its interface with anactuating member 149 as the actuating member 149 pivots through itsrange of motion about pins 149 b.

FIG. 39A shows the actuating member 149 fully advanced. The selectormechanism 146 is positioned over the left needle 144 where the shuttleactuator 146 b maneuvers the shuttle 151 through the channel 149 e ofthe actuating member 149 onto the left needle 144 and the follower pin146 d is engaged in the left advancing track 149 g of the actuatingmember 149.

FIG. 39B shows the selector mechanism 146 in position over the leftneedle 144 and the actuating member 149 fully retracted as evidenced bythe rearward motion of the lever 149 a about pins 149 b. As the followerpin 146 d travels in the left advancing track 149 g of the actuatingmember 149, the shuttle 151 exits the shuttle actuator 146 b of theselector mechanism 146 and fully advances the left needle 144 while theright needle 145 remains fully retracted.

FIG. 39C shows the selector mechanism 146 in position over the leftneedle 144 and the actuating member 149 returned to its fully advancedstate as indicated by the forward motion of the lever 149 a about pins149 b. The follower pin 146 d remains in the left advancing track 149 gof the actuating member 149 while the shuttle 151 returns to the shuttleactuator 146 b thus retracting the left needle 144.

FIG. 39D shows the actuating member 149 fully advanced. The selectormechanism 146 is positioned over the right needle 145 where the shuttleactuator 146 b maneuvers the shuttle 151 through the channel 149 e ofthe actuating member 149 onto the right needle 145 and the follower pin146 d traverses the selection track 149 j of the actuating member 149.With the actuating member 149 in its fully advanced state, the selectormechanism 146 can only now be activated precluding the selection processduring advancement of the left needle 144 or right needle 145 asselection of the left needle 144 or right needle 145 is only desiredwhile both the left needle 144 or right needle 145 are fully retracted.

FIG. 39E shows the selector mechanism 146 in position over the rightneedle 145 and the actuating member 149 fully retracted as evidenced bythe rearward motion of the lever 149 a about pins 149 b. As the followerpin 146 d travels in the right advancing track 149 h of the actuatingmember 149, the shuttle 151 exits the shuttle actuator 146 b of theselector mechanism 146 and fully advances the right needle 145 while theleft needle 144 remains fully retracted.

FIG. 39F shows the selector mechanism 146 in position over the rightneedle 145 and the actuating member 149 returned to its fully advancedstate as indicated by the forward motion of the lever 149 a about pins149 b. The follower pin 146 d remains in the right advancing track 149 hof the actuating member 149 while the shuttle 151 returns to the shuttleactuator 146 b thus retracting the right needle 145.

FIG. 40A is a perspective view of the adapter 154 and spring arms 156.The adapter 154 is fixedly attached to the housing 143 via two flanges154 d and coupled to the selector mechanism 146 by way of the post 154c. The mounting end 156 a of spring arms 156 attach to the adapter 154at the mounting holes 154 a. The mounting holes 154 a are of a diameterthat allows a secure fit of the mounting ends 156 a of the spring arms156 such that the spring arms 156 cannot freely move. The followers 156b of the spring arms 156 then locate into the follower holes 154 b ofthe adapter 154. The follower holes 154 b are of a diameter that isslightly larger than the followers 156 b of the spring arms 156 to allowfor free vertical movement of the followers 156 b. This feature permitsthe spring arm 156 to engage the rotation cam 155 at all times under alight pressure. The adapter 154 can be manufactured via plasticinjection molding and the spring arms 156 are comprised of rigidlyformed stainless steel wire.

FIG. 40B is a proximal perspective view of the adapter 154 showing therotation cam bores 154 f through which the rotation cams 155 pass. It isthrough the rotation cam bores 154 f that the rotation cams 155 areinstalled in order to engage the followers 156 b of the spring arms 156.Also visible from this vantage point is the suture routing tube passage154 e that allows for the routing of the suture routing tube 47 whilemaintaining its position safely away from the path of the rotation cams155.

FIGS. 41A-41E detail the operational aspects of the rotation cam 155through a variety of views. The rotation cam 155 allows for the rotationof the left needle 144 or right needle 145 upon initiation of theactuating member 149. The rotation cam 155 incorporates features thatallow for straight advancing of the left needle 144 or right needle 145while also allowing for the 90 degree rotation of each duringretraction. Other aspects of the rotation cam 155 prevent undesiredoperation during the operation of suturing instrument 16 via variousinterlocks engaged by the follower 156 b of the spring arm 156. Therotation cam can be precision manufactured of stainless steel or othermedical-grade rigid material via a machining process, metal injectionmolding process, or even a selective laser sintering process.

FIG. 41A is a side view of the rotation cam 155 showing an advancingtrack 155 b and a rotation track 155 c. Each advancing track 155 b androtation track 155 c are represented every 90 degrees along thecircumference of the rotation cam 155. This permits the advancing andsubsequent rotation upon retraction of the left needle 144 or rightneedle 145 when the actuating member 149 is employed. At the end of eachadvancing track 155 b there is an advancing stop 155 d which is, inessence, a fall-off for the follower 156 b of spring arm 156 so that thefollower 156 b cannot travel backward in the advancing track 155 b. Thesame fall-off feature, a rotation stop 155 e, is incorporated at the endof the rotation track 155 c so that once the follower 156 b of thespring arm 156 falls off the rotation stop 155 e end of the rotationtrack 155 c, the follower 156 b cannot travel in retrospect through therotation track 155 c of rotation cam 155. This series of stops sanctionsthe continuous 360 degree rotation of the left needle 144 or rightneedle 145 in 90 degree increments in only direction.

FIG. 41B is a cross-sectional view of the rotation cam 155 of FIG. 41Ashowing the needle bore 155 a through which the left needle 144 or rightneedle 145 can pass through and affix via a shrink fit process, welding,or by the use of adhesives. In this view, the four advancing tracks 155b are visible. Each advancing track 155 b consists of an advancing ramp155 f that the follower 156 b of spring arm 156 must follow, risinguntil it eventually falls off at the advancing stop 155 d.

FIG. 41C is a side view of a flat pattern of the rotation cam 155 camprofile. Note the orientation of the advancing tracks 155 b and rotationtracks 155 c every 90 degrees. Readily visible are the advancing stop155 d and the rotation stop 155 e.

FIG. 41D is a perspective view of the rotation cam 155 along with theneedle bore 155 a. The advancing track 155 b and rotation track 155 care visible. Also evident is an advancing stop 155 d created by theintersection of the advancing ramp 155 f and rotation track 155 b and arotation stop 155 e formed at the intersection of the rotation ramp 155g and the advancing track 155 b.

FIG. 41E is a cross-sectional view of the rotation cam 155 of FIG. 41Ddetailing the needle bore 155 a through which the left needle 14 orright needle 145 can pass and be fastened unto and also showing theadvancing track 155 b along with its advancing ramp 155 f and itsconsequent advancing stop 155 d. The rotation stop 155 e is shownintersecting with the advancing track 155 b after falling off abruptlyfrom the rotation ramp 155 g (FIG. 41D).

FIG. 42 is a perspective view of a typical left needle 144 showing thespherical member 148 attached to the non-tissue engaging end 144 a. Notethat the same features do apply to the right needle 145.

FIG. 42A is a detail view of the tissue-engaging end 144 b of the needle144 of FIG. 42 showing the engaging latch surface 144 d, which whenoriented towards the ferrule latch 153 extends down radially to pushdown upon the ferrule latch 153, thereby moving the ferrule contact edge153 f out of the path of the ferrule 103. It is this feature that allowsthe suture 105 and its attached ferrule 103 to be removed from itsferrule compartment 152 h of the distal tip 152. As the needle 144advances into the ferrule 103 the ferrule latch 153 is engaged by one ofthe engaging latch surfaces 144 d, thus the ferrule latch 153 will beforced down allowing withdrawal of the ferrule 103 and its attachedsuture 105.

FIG. 42B is a detail view of the tissue-engaging end 144 b of the needle144 of FIG. 42 showing the non-engaging latch surface 144 c. It is thisfeature that allows the suture 105 and its attached ferrule 103 to bereset into its ferrule compartment 152 h of the distal tip 152. As theneedle 144 returns the ferrule 103 to its compartment 152 h, the ferrulelatch 153 is not engaged because this surface is faceted or has ashorter radial length, thus the ferrule latch 153 will remain extendedengaging and retaining the ferrule 103 with its ferrule contact edge 153f upon needle 144 retraction.

FIGS. 43-47B detail the sequence of operation induced by the actuationof the actuating member 149, advancing and subsequent retraction of theleft needle 144 (note that the same sequence applies to the right needle145 which is not shown in this sequence to better illustrate thecomplete cycling of the left needle 144), and the function of therotation cam 155.

FIG. 43 is a partial right perspective view of the instrument 16 withhousing 143 removed showing a partial cross-section of the adapter 154.The actuating member 149 is fully advanced and the ball pocket 151 b ofthe shuttle 151 is retaining the spherical member 148 of the needle 144in its fully retracted position. The rotation cam 155 is fullyretracted, and the follower 156 b of the spring arm 156 is engaged inthe trough of the advancing track 155 b of the rotation cam 155.

FIG. 43A is an enlarged view of the adapter 154, rotation cam 155, andspring arm 156 of FIG. 43. Note that the follower 156 b of the springarm 156 is fully engaged in the advancing track 155 b of the fullyretracted rotation cam 155.

FIG. 43B is an enlarged view of the tissue engaging end 144 b of theneedle 144 showing its orientation with respect to the sequence shown inFIG. 43. The engaging latch surfaces 144 d are oriented vertically toengage the ferrule latch 153.

FIG. 44 is a partial right perspective view of the instrument 16 withhousing 143 removed showing a partial cross-section of the adapter 154.The actuating member 149 is partially retracted as evidenced by therearward movement of the lever 149 a pivoting about pins 149 b. Thespherical member 148 retained in the ball pocket 151 b of the shuttle151 is partially advanced thus partially advancing the left needle 144.The rotation cam 155 begins it advance and the follower 156 b of thespring arm 156 rises as it follows the advancing ramp 155 f of theadvancing track 155 b of the rotation cam 155.

FIG. 44A is an enlarged view of the adapter 154, rotation cam 155, andspring arm 156 of FIG. 44. Note that the follower 156 b of the springarm 156 is beginning to rise as it rides up the advancing ramp in theadvancing track 155 b of the partially advanced rotation cam 155.

FIG. 45 is a partial right perspective view of the instrument 16 withhousing 143 removed showing a partial cross-section of the adapter 154.The actuating member 149 is fully retracted as evidenced by the rearwardmovement of the lever 149 a pivoting about pins 149 b. The sphericalmember 148 retained in the ball pocket 151 b of the shuttle 151 is fullyadvanced thus completely advancing the needle 144. The rotation cam 155is fully advanced and the follower 156 b of the spring arm 156 falls offthe advancing stop 155 d at the end of the advancing ramp 155 f andcontinues to the end of the advancing track 155 b of the rotation cam155.FIG. 45A is an enlarged view of the adapter 154, rotation cam 155,and spring arm 156 of FIG. 45. Note that the follower 156 b of thespring arm 156 falls as it passes the advancing stop 155 d precluding itfrom traversing back through the advancing track 155 b of the fullyadvanced rotation cam 155.

FIG. 45B is an enlarged view of the tissue engaging end 144 b of theneedle 144 showing its orientation with respect to the sequence shown inFIG. 45. The engaging latch surfaces 144 d are oriented vertically toengage the ferrule latch 153.

FIG. 46 is a partial right perspective view of the instrument 16 withhousing 143 removed showing a partial cross-section of the adapter 154.The actuating member 149 is partially advanced as evidenced by theforward movement of the lever 149 a pivoting about pins 149 b. Thespherical member 148 retained in the ball pocket 151 b of the shuttle151 begins retracting thus retracting the needle 144. The rotation cam155 begins its retraction and partial rotation as the follower 156 b ofthe spring arm 156 travels through the rotation track 155 c and rises asit progress up the rotation ramp 155 g of the rotation cam 155.

FIG. 46A is an enlarged view of the adapter 154, rotation cam 155, andspring arm 156 of FIG. 46. Note that the follower 156 b of the springarm 156 rises as it passes the advancing stop 155 d (which is rotatedout of view) into to the rotation track 155 c and up the rotation ramp155 g of the partially retracted rotation cam 155.

FIG. 46B is an enlarged view of the tissue engaging end 144 b of theneedle 144 showing its orientation with respect to the sequence shown inFIG. 46. The engaging latch surfaces 144 d are rotated slightly,bringing the non-engaging latch surfaces 144 c closer to vertical.

FIG. 47 is a partial right perspective view of the instrument 16 withhousing 143 removed showing a partial cross-section of the adapter 154.The actuating member 149 is fully advanced as evidenced by the forwardmovement of the lever 149 a pivoting about pins 149 b. The sphericalmember 148 retained in the ball pocket 151 b of the shuttle 151 is fullyretracted thus completely retracting the needle 144. The rotation cam155 completes its retraction and full 90 degree rotation as the follower156 b of the spring arm 156 travels through the rotation track 155 c,falls off the rotation stop 155 e at the end of the rotation ramp 155 g(which have rotated out of view) and continues into the next advancingtrack 155 b of rotation cam 155.

FIG. 47A is an enlarged view of the adapter 154, rotation cam 155, andspring arm 156 of FIG. 47. Note that the follower 156 b of the springarm 156 falls as it passes the rotation stop precluding it fromtraversing back into the rotation track 155 c of the fully retractedrotation cam 155.

FIG. 47B is an enlarged view of the tissue engaging end 144 b of theneedle 144 showing its orientation with respect to the sequence shown inFIG. 47. The needle 144 has completed its 90 degree rotation and thenon-engaging latch surfaces 144 c are oriented vertically so as to notengage the ferrule latch 153.

FIG. 48 is a partial perspective view of the underside of the distal end16 a of instrument 16. The ferrule latch 153 is inserted into the latchpocket 152 g of the distal tip 152. The ferrule latch 153 can beretained via force fit, adhesive, or welding and can be made frommedical grade stainless steel or materials with a high elasticity.

FIG. 49A is a perspective view of the ferrule latch 153 of FIG. 48.Detailed is the functioning of the ferrule latch 153 when engaged by theleft needle 144. The engaging latch surface 144 d of the left needle 144advances past a needle ramp 153 g and onto the left needle relief 153 dforcing the ferrule latch 153 on its rigid base 153 a to flex at theupper spring section 153 b pushing the ferrule contact edge down andconsequently releasing the ferrule 103 from its ferrule compartment 152h in the distal tip 152.

FIG. 49B is a perspective view of the ferrule latch 153 of FIG. 48.Detailed is the functioning of the ferrule latch 153 when engaged by theright needle 145. The engaging latch surface 145 d of the right needle145 advances past a needle ramp 153 g and onto the right needle relief153 e forcing the ferrule latch 153 on its rigid base 153 a to flex atthe lower spring section 153 c pushing the ferrule contact edge down andconsequently releasing the ferrule 103 from its ferrule compartment 152h in the distal tip 152.

FIG. 50A-50J are perspective views of the underside of the distal end 16a of the instrument 16 exhibiting the sequence of events transpiring asthe left needle 144 is actuated by the employment of the actuatingmember 149 as applied to the ferrule latch 153 and the ferrule 103 andits attached suture 105. Note that in addition to the left needle 144,the following operations can be utilized to describe the right needle145.

FIG. 50A represents the instrument 16 with the actuating member 149fully advanced. Both the left needle 144 and right needle 145 are fullyretracted inside the distal tip 152. The ferrule latch 153 rests, fullyextended, inside the latch pocket 152 g of the distal tip 152. Bothferrules 103 and attached sutures 105 are retained in their respectiveferrule compartments 152 h by the ferrule latch 153 and is bestdescribed by the actuating member 149 and rotation cam 155 operationillustrated in FIG. 43 and 43A.

FIG. 50B represents the instrument 16 with the actuating member 149partially retracted. The left needle 144 begins to advance across thejaw 152 f of the distal tip 152. The ferrule latch 153 rests, fullyextended, inside the latch pocket 152 g of the distal tip 152. Bothferrules 103 and attached sutures 105 are retained in their respectiveferrule compartments 152 h by the ferrule latch 153 and is bestdescribed by the actuating member 149 and rotation cam 155 operationillustrated in FIG. 44 and 44A.

FIG. 50C represents the instrument 16 with the actuating member 149fully retracted. The left needle 144 has fully traversed the jaw 152 fof the distal tip 152. The engaging latch surface 144 d (most visible inFIG. 50B) of the left needle 144 contacts the left needle relief 153 d(most visible in FIG. 50B) of the ferrule latch 153 and in turn forcesthe upper spring section 153 b of the ferrule latch 153 to flex downwardand release the ferrule 103 from its ferrule compartment 152 h and isbest described by the actuating member 149 and rotation cam 155operation illustrated in FIG. 45 and 45A. FIG. 50D represents theinstrument 16 with the actuating member 149 partially advanced. The leftneedle 144 begins to retract back across the jaw 152 f of the distal tip152 and start its 90 degree rotation so as to return the ferrule 103 toits compartment 152 h on the next actuating member 149 employmentsequence. The ferrule latch 153 free of the engaging latch surface 144 dof the left needle 144 fully extends inside the latch pocket 152 g ofthe distal tip 152. The left ferrule 103, now affixed to the left needle144 and free from its ferrule compartment 152 h also traverses the jaw152 f of the distal tip 152 and is best described by the actuatingmember 149 and rotation cam 155 operation illustrated in FIG. 46 and46A.

FIG. 50E represents the instrument 16 with the actuating member 149fully advanced. The left needle 144 fully retracts across the jaw 152 fand into the distal tip 152 and completes its 90 degree rotation toreturn the ferrule 103 to its compartment 152 on the next actuatingmember 149 employment sequence and is best described by the actuatingmember 149 and rotation cam 155 operation illustrated in FIG. 47 and47A.

FIG. 50F represents the instrument 16 with the actuating member 149partially retracted. The left needle 144 with the non-engaging latchsurface 144 c now vertical partially advances across the jaw 152 f as toreturn the ferrule 103 to its compartment 152 h and is best described bythe actuating member 149 and rotation cam 155 operation illustrated inFIG. 44 and 44A.

FIG. 50G represents the instrument 16 with the actuating member 149fully retracted. The left needle 144 is fully advanced across the jaw152 f returning the ferrule 103 to its compartment 152 h with thenon-engaging latch surface 144 c now vertical, the left needle 144 doesnot engage the left needle relief 153 d (best viewed in FIG. 50H), andconsequently the ferrule latch 153 does not flex and remains in positionto retain the ferrule 103 and is best described by the actuating member149 and rotation cam 155 operation illustrated in FIG. 45 and 45A.

FIG. 50H represents the instrument 16 with the actuating member 149partially advanced. The left needle 144 begins to retract back acrossthe jaw 152 f of the distal tip 152 and start another 90 degree rotationso as to remove the ferrule 103 from its compartment 152 h on the nextactuating member 149 employment sequence. The ferrule latch 153 free ofthe engaging latch surface 144 d of the left needle 144 is fullyextended and inside the latch pocket 152 g of the distal tip 152 andretains the ferrules 103 and is best described by the actuating member149 and rotation cam 155 operation illustrated in FIG. 46 and 46A.

FIG. 50J represents the instrument 16 with the actuating member 149fully advanced. Both the left needle 144 and right needle 145 are fullyretracted inside the distal tip 152. The ferrule latch 153 rests, fullyextended, inside the latch pocket 152 g of the distal tip 152. Bothferrules 103 and attached sutures 105 are retained in their respectiveferrule compartments 152 h by the ferrule latch 153 and is bestdescribed by the actuating member 149 and rotation cam 155 operationillustrated in FIG. 47 and 47A.

FIG. 51A depicts the first step in tying a novel knot with theinstrument 16 of FIG. 31. This step is known as a “surgeon's” knot andis used for apposing the tissue 159. The suture 105 having been passedthrough opposing tissue 159 is arranged such that the ferrule end 158 bof the suture 105 is passed over the free end 158 a of the suture 105,then under the free end 158 a of the suture 105, then finally throughthe closed loop created by the free end 158 a and ferrule end 158 b ofthe suture 105. This process is conducted a total of two times toproduce two throws 158 c of the ferrule end 158 b of suture 105 aroundthe free end 158 a of the suture 105.

FIG. 51B shows the correct procedure for sliding the two throws 158 cproduced in FIG. 51A towards the wound closure site of the tissue 159.The instrument 16 of FIG. 31 is maneuvered such that the ferrule end 158b of the suture 105 is pulled taut and straight while the free end 158 aof the suture 105 forms the two throws 158 c created in FIG. 51A and canbe advanced towards the closure site of the tissue 159.

FIG. 51C depicts the second step in tying the knot with the instrument16 of FIG. 31. This step is referred to as an “end-point” knot and isused to stabilize the suture 105 and help to secure the surgeon's knotperformed in FIGS. 51A and 51B. The suture 105 is again arranged suchthat the ferrule end 158 b of the suture 105 is passed over the free end158 a of the suture 105, then under the free end 158 a of the suture105, then finally through the closed loop created by the free end 158 aand ferrule end 158 b of the suture 105. This process creates one throw158 c about the free end 158 a of the suture 105.

FIG. 51D shows the procedure for sliding the throw 158 c produced inFIG. 53C towards the wound closure site of the tissue 159. Theinstrument 16 of FIG. 31 is maneuvered such that the ferrule end 158 bof the suture 105 is pulled taut and the free end 158 a of the suture105 forms the throw 158 c created in FIG. 51C and can be advancedtowards the closure site of the tissue 159 onto the surgeon's knotcreated in FIGS. 51A and 51B.

FIG. 51E depicts the third step in tying knot with the instrument 16 ofFIG. 31. This step is referred to as “locking” and is used to secure thesuture 105 and lock over the end-point knot performed in FIGS. 51C and51D. The suture 105 is again arranged such that the ferrule end 158 b ofthe suture 105 is passed over the free end 158 a of the suture 105, thenunder the free end 158 a of the suture 105, then finally through theclosed loop created by the free end 158 a and ferrule end 158 b of thesuture 105. This process creates one throw 158 c about the free end 158a of the suture 105.

FIG. 51F shows the procedure for advancing the throw 158 c produced inFIG. 51E towards the wound closure site of the tissue 159. At thispoint, the free end 158 a of the suture 105 is pulled taut and the throw158 c created in FIG. 51E now formed from the ferrule end 158 b of thesuture 105 can be advanced towards the closure site of the tissue 159and onto the end-point knot created in FIGS. 51C and 51D. By producingthe closed loop throw 158 c in the ferrule end 158 b of the suture 105instead of the free end 158 a of the suture 105 as shown in FIGS. 51Aand 51B, both the free end 158 a of suture 105 and the ferrule end 158 bof the suture 105 will have tight bends and will effectively lock theknot.

FIG. 51G depicts the fourth step in tying this knot with the instrument16 of FIG. 31. This step is referred to as a “finishing” knot and isused to secure the suture 105 over the locking knot performed in FIGS.51E and 51F, providing sufficient holding forces to maintain the lockingknot and conclude the knot tying process, but more throws 158 c can beplaced if desired by the operator. The suture 105 is again arranged suchthat the ferrule end 158 b of the suture 105 is passed over the free end158 a of the suture 105, then under the free end 158 a of the suture105, then finally through the closed loop created by the free end 158 aand ferrule end 158 b of the suture 105. This process creates one throw158 c about the free end 158 a of the suture 105.

FIG. 51H shows the procedure for sliding the throw 158 c produced inFIG. 51G towards the wound closure site of the tissue 159. Theinstrument 16 of FIG. 31 is maneuvered such that the ferrule end 158 bof the suture 105 is taut and the free end 158 a of the suture 105 andthe throw 158 c created in FIG. 51C can be advanced towards the closuresite of the tissue 159 and onto the locking knot created in FIGS. 51Eand 51F.

The foregoing examples of specific compositions, processes, articlesand/or apparatus employed in the practice of the present invention are,of course, intended to be illustrative rather than limiting, and it willbe apparent the numerous variations and modification of these specificembodiments may be practiced within the scope of the appended claims.

1. A surgical suturing instrument comprising: a housing having a handleand an actuating member; an elongated guide member attached to thehousing, and having a distal end; first and second needles extendingfrom the housing through the shaft to the distal end; a selector forselectively coupling the actuating member to a selected one of the firstand second needles
 2. The surgical suturing instrument of claim 1 inwhich the actuating member is pivotally mounted in the housing.
 3. Thesurgical suturing instrument of claim 2 in which the actuating membercomprises a pair of pins.
 4. The surgical suturing instrument of claim 2comprising an extension spring attached to the actuating member and thehousing biasing the actuating member to a forward position.
 5. Thesurgical suturing instrument of claim 1 in which the actuating memberincludes first and second grooves receiving the first and secondneedles.
 6. The surgical suturing instrument of claim 1 in which at eachof the first and second needles comprises a ball at a proximal endthereof.
 7. The surgical suturing instrument of claim 6 comprising ashuttle coupled to the selector and movable between a first positionengaging the first needle, and a second position engaging the secondneedle.
 8. The surgical suturing instrument of claim 7 in which theshuttle includes a channel receiving the ball at the proximal end of aselected one of the first and second needles, coupling the selectedneedle to the actuator so that the actuator drives the selected needlebetween an extended position and a retracted position.
 9. The surgicalsuturing instrument of claim 1 comprising a suture routing tubeextending from the handle through the housing.
 10. The surgical suturinginstrument of claim 1 in which the longitudinal guide member includes asuture channel and first and second needle tracks.
 11. The surgicalsuturing instrument of claim 1 comprising an adaptor in the housingattached to the longitudinal guide member.
 12. The surgical suturinginstrument of claim 11 comprising a shaft receiving the longitudinalguide member.
 13. The surgical suturing instrument of claim 12 in whichthe shaft is attached to the adapter by a threaded nut.
 14. The surgicalsuturing instrument of claim 13 comprising a gasket disposed between theshaft and the adapter.
 15. The surgical suturing instrument of claim 13in which the shaft and the adapter comprise mating D-shaped profiles.16. The surgical suturing instrument of claim 9 in which the gasketcomprising a ring sealing to a suture routing tube, and first and secondneedle holes.
 17. The surgical suturing instrument of claim 16 in whichthe gasket comprises sealing flaps sealing to the first and secondneedles.
 18. The surgical suturing instrument of claim 12 comprising adistal tip attached to the shaft.
 19. The surgical suturing instrumentof claim 18 in which the distal tip comprises a front section, a jawopening, and a ferrule latch pocket.
 20. The surgical suturinginstrument of claim 19 comprising a ferrule latch disposed in theferrule latch pocket.
 21. The surgical suturing instrument of claim 1comprising an interlock for inhibiting movement of the selector exceptwhen the actuating member is in a forward position.
 22. The surgicalsuturing instrument of claim 21 in which the actuating member comprisesa selection track, a first advancing track and a second advancing track.23. The surgical suturing instrument of claim 22 in which the selectorcomprises a follower pin engaged in the selector track when theactuating member is in a forward position, and in one of the firstadvancing track or the second advancing track when the actuating memberis in an advanced position.
 24. The surgical suturing instrument ofclaim 7 in which the selector comprises an arm pivotally mounted in thehousing so that the selector is constrained to move in a back and forthmotion.
 25. The surgical suturing instrument of claim 24 in which theselector comprises a shuttle actuator coupled to the shuttle.
 26. Thesurgical suturing instrument of claim 25 in which the shuttle comprisesa tongue engaging a longitudinal shuttle groove in the shuttle actuator.27. The surgical suturing instrument of claim 11 in which the adaptercomprises first and second rotation cams attached to the first andsecond needles, and first and second cam followers.
 28. The surgicalsuturing instrument of claim 27 in which the first and second camfollowers comprise spring arms mounted to the adapter.
 29. The surgicalsuturing instrument of claim 28 in which the adapter comprises first andsecond follower holes through which the first and second cam followersextend.
 30. The surgical suturing instrument of claim 27 in which theadapter comprises first and second rotation bores receiving the firstand second rotation cams.
 31. The surgical suturing instrument of claim27 in which the first and second rotation cams comprise an advancingtrack and a rotation track.
 32. The surgical suturing instrument ofclaim 31 in which the first and second advancing tracks comprise firstand second advancing stops preventing the cam followers from followingthe advancing tracks in a backward direction.
 33. The surgical suturinginstrument of claim 31 in which the rotation track extends over 90degrees.
 34. The surgical suturing instrument of claim 31 in which thefirst and second rotation tracks comprise first and second rotationstops preventing the cam followers from following the rotation tracks ina backward direction.
 35. The surgical suturing instrument of claim 20in which the first and second needles comprise a tissue engaging endhaving a latch engaging surface.
 36. The surgical suturing instrument ofclaim 35 in which the ferrule latch comprises a ferrule contact edgeselectively engaging a ferrule for stripping the ferrule off the needle.37. The surgical suturing instrument of claim 36 in which the latchengaging surface engages the ferrule latch and moves the ferrule contactedge to a retracted position where it does not engage the ferrule. 38.The surgical suturing instrument of claim 35 in which the first andsecond needles comprises a non latch engaging surface.
 39. The surgicalsuturing instrument of claim 38 in which the latch engaging surface andthe non latch engaging surface are arranged radially around the tissueengaging ends of the first and second needles.
 40. The surgical suturinginstrument of claim 39 comprising two latch engaging surfaces and twonon latch engaging surfaces disposed in an alternating arrangementaround the tissue engaging ends of the first and second needles.
 41. Thesurgical suturing instrument of claim 20 in which the ferrule latchcomprises a base disposed in the ferrule latch pocket.
 42. The surgicalsuturing instrument of claim 41 in which the ferrule latch comprises aneedle engaging portion connected to the base by a resilient spring. 43.The surgical suturing instrument of claim 42 in which the needleengaging portion comprises first and second needle relief grooves. 44.The surgical suturing instrument of claim 42 in which the needleengaging portion comprises a needle ramp.
 45. The surgical suturinginstrument of claim 42 in which the first and second needles comprise atissue engaging end having a ferrule latch engaging surface.
 46. Thesurgical suturing instrument of claim 45 in which the ferrule latchcomprises a ferrule contact edge selectively engaging a ferrule forstripping the ferrule off the needle.
 47. The surgical suturinginstrument of claim 46 in which the ferrule latch engaging surfaceengages the ferrule latch and moves the ferrule contact edge to aretracted position where it does not engage the ferrule.
 48. Thesurgical suturing instrument of claim 45 in which the first and secondneedles comprises a non ferrule latch engaging surface.
 49. The surgicalsuturing instrument of claim 48 in which the ferrule latch engagingsurface and the non ferrule latch engaging surface are arranged radiallyaround the tissue engaging ends of the first and second needles.
 50. Thesurgical suturing instrument of claim 49 comprising two ferrule latchengaging surfaces and two non ferrule latch engaging surfaces disposedin an alternating arrangement around the tissue engaging ends of thefirst and second needles.
 51. The surgical suturing instrument of claim50 in which the adapter comprises first and second rotation camsattached to the first and second needles, and first and second camfollowers.
 52. The surgical suturing instrument of claim 51 in which thefirst and second cam followers comprise spring arms mounted to theadapter.
 53. The surgical suturing instrument of claim 52 in which theadapter comprises first and second follower holes through which thefirst and second cam followers extend.
 54. The surgical suturinginstrument of claim 51 in which the adapter comprises first and secondrotation bores receiving the first and second rotation cams.
 55. Thesurgical suturing instrument of claim 51 in which the first and secondrotation cams comprise an advancing track and a rotation track.
 56. Thesurgical suturing instrument of claim 55 in which the first and secondadvancing tracks comprise first and second advancing stops preventingthe cam followers from following the advancing tracks in a backwarddirection.
 57. The surgical suturing instrument of claim 55 in which therotation track extends over 90 degrees.
 58. The surgical suturinginstrument of claim 55 in which the first and second rotation trackscomprise first and second rotation stops preventing the cam followersfrom following the rotation tracks in a backward direction.
 59. Thesurgical suturing instrument of claim 20 in which the distal tipcomprises first and second ferrule compartments.
 60. The surgicalsuturing instrument of claim 59 in which the ferrule latch is disposedadjacent the first and second ferrule compartments for selectivelyretaining first and second ferrules in the first and second ferrulecompartments.
 61. A surgical suture comprising: a length of suturematerial having a first end; a ferrule attached to the first end of thelength of suture; a protective sleeve covering a portion of the ferruleand a portion of the length of suture to protect the suture end fromdamage.
 62. The surgical suture of claim 61 in which the ferrulecomprises a reduced diameter suture-engaging sleeve.
 63. The surgicalsuture of claim 62 in which the protective sleeve covers a portion ofthe reduced diameter suture-engaging sleeve.
 64. A ferrule assembly forattaching to an end of a length of surgical suture comprising: agenerally cylindrical ferrule having a needle receiving opening; aleader connected to the ferrule.
 65. The ferrule assembly of claim 64 inwhich the leader comprises a semi-rigid material.
 66. The ferruleassembly of claim 65 in which the leader comprises stainless steel wire,cable, or monofilament.
 67. The ferrule assembly of claim 64 comprisinga ball attached to an end of the leader opposite the ferrule.
 68. Theferrule assembly of claim 67 comprising a suture having a ball receivingsleeve attached to one end there of.
 69. The ferrule assembly of claim68 in which the ball receiving sleeve is crimped to the suture.
 70. Theferrule assembly of claim 68 in which the ball receiving sleevecomprises stainless steel.
 71. The ferrule assembly of claim 68 in whichthe ball is disposed in the ball-receiving sleeve.
 72. A method of tyinga closed loop of suture having a ferrule end and a free end using asurgical suturing instrument having a jaw comprising the steps of: a)passing the ferrule end of the suture through a tissue section; b)passing the ferrule end over the free end above the loop; c) positioningthe free end inside the jaw so that the ferrule end passes under thefree end; and d) drawing the ferrule end through the loop.
 73. Themethod of tying a closed loop of suture of claim 72 comprising repeatingsteps b, c, and d to form two throws.
 74. The method of tying a closedloop of suture of claim 73 comprising pulling the ferrule end of thesuture taut, and advancing the two throws towards the tissue.
 75. Themethod of tying a closed loop of suture of claim 74 comprising: passingthe ferrule end over the free end of suture; passing the ferrule endunder the free end of the suture; passing the ferrule end through theclosed loop created by the free end and the ferrule end of the suture toform a throw.
 76. The method of tying a closed loop of suture of claim75 comprising: pulling the ferrule end of the suture taut, and slidingthe throw towards the tissue to create an end point knot.
 77. The methodof tying a closed loop of suture of claim 76 comprising: passing theferrule end of the suture over the free end; passing the ferrule end ofthe suture under the free end to form a closed loop; passing the ferruleend of the suture through the closed loop created by the free end andthe ferrule end of the suture to create a throw about the free end. 78.The method of tying a closed loop of suture of claim 77 comprisingpulling the free end taut, and advancing the throw towards the end pointknot to create a lock knot.
 79. The method of tying a closed loop ofsuture of claim 78 comprising: passing the ferrule end of the sutureover the free end; passing the ferrule end of the suture under the freeend to form a closed loop; passing the ferrule end of the suture throughthe closed loop to create a throw.
 80. The method of tying a closed loopof suture of claim 79 comprising pulling the ferrule end of the suturetaut, and advancing the throw towards the lock knot to form a finishingknot.
 81. A surgical suturing instrument comprising: a housing having ahandle and an actuating member; an elongated guide member attached tothe housing and having a distal end; a reciprocally movable needleextending from the housing through the elongated guide member to thedistal end; an actuator coupled between the actuating member and theneedle for successively moving the needle between an extended positionand a retracted position, and rotating the needle.
 82. A surgicalsuturing instrument comprising: a ferrule holding tip adjacent to atissue receiving gap; a reciprocally movable needle movable across thetissue receiving gap to engage the ferrule holding tip; a ferrulestripper movable between a first position in proximity with the needlefor stripping a ferrule off the needle and a second position.
 83. Thesurgical suturing instrument of claim 82 in which the ferrule strippermoves between the first and second positions on successive movements ofthe needle across the gap.
 84. The surgical suturing instrument of claim83 in which the ferrule stripper is responsive to the rotationalposition of the needle, and including an actuator coupled to the needlefor rotating the needle.